Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-05 @ 5:36 PM
Study NCT ID:
NCT02087904
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2014-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
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AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to Week 52 (or last dose of study drug) plus 70 days', 'description': 'Safety population: all participants who took at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W', 'otherNumAtRisk': 85, 'otherNumAffected': 66, 'seriousNumAtRisk': 85, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W', 'otherNumAtRisk': 89, 'otherNumAffected': 63, 'seriousNumAtRisk': 89, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W', 'otherNumAtRisk': 85, 'otherNumAffected': 65, 'seriousNumAtRisk': 85, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'ABT-981 200 mg', 'description': 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Week 26', 'unitOfMeasure': 'mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '-0.057', 'upperLimit': '0.193'}, {'value': '-0.01', 'groupId': 'OG001', 'lowerLimit': '-0.130', 'upperLimit': '0.113'}, {'value': '-0.08', 'groupId': 'OG002', 'lowerLimit': '-0.205', 'upperLimit': '0.043'}, {'value': '-0.07', 'groupId': 'OG003', 'lowerLimit': '-0.196', 'upperLimit': '0.048'}]}]}], 'analyses': [{'pValue': '0.384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.249', 'ciUpperLimit': '0.096', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.095', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.324', 'ciUpperLimit': '0.026', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.106', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.314', 'ciUpperLimit': '0.03', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'Semi-quantitative synovitis/effusion volume WORMS scores were scored as normal (0), \\< 33% of maximum estimated distention (1), 33% - 66% of maximum estimated distention (2), or \\> 66% of maximum estimated distention (3).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.7', 'groupId': 'OG000', 'lowerLimit': '-35.30', 'upperLimit': '-22.15'}, {'value': '-29.8', 'groupId': 'OG001', 'lowerLimit': '-36.27', 'upperLimit': '-23.32'}, {'value': '-36.3', 'groupId': 'OG002', 'lowerLimit': '-42.90', 'upperLimit': '-29.69'}, {'value': '-32.1', 'groupId': 'OG003', 'lowerLimit': '-38.64', 'upperLimit': '-25.63'}]}]}], 'analyses': [{'pValue': '0.818', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-10.22', 'ciUpperLimit': '8.08', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.109', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.6', 'ciLowerLimit': '-16.83', 'ciUpperLimit': '1.69', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.465', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-12.58', 'ciUpperLimit': '5.76', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '-29.7', 'groupId': 'OG000', 'lowerLimit': '-36.61', 'upperLimit': '-22.75'}, {'value': '-31.8', 'groupId': 'OG001', 'lowerLimit': '-38.62', 'upperLimit': '-24.98'}, {'value': '-38.9', 'groupId': 'OG002', 'lowerLimit': '-45.83', 'upperLimit': '-31.92'}, {'value': '-36.9', 'groupId': 'OG003', 'lowerLimit': '-43.71', 'upperLimit': '-30.00'}]}]}], 'analyses': [{'pValue': '0.666', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-11.76', 'ciUpperLimit': '7.52', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.065', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.2', 'ciLowerLimit': '-18.95', 'ciUpperLimit': '0.56', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.145', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.2', 'ciLowerLimit': '-16.84', 'ciUpperLimit': '2.49', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.9', 'groupId': 'OG000', 'lowerLimit': '-40.66', 'upperLimit': '-25.12'}, {'value': '-36.1', 'groupId': 'OG001', 'lowerLimit': '-43.76', 'upperLimit': '-28.46'}, {'value': '-38.7', 'groupId': 'OG002', 'lowerLimit': '-46.52', 'upperLimit': '-30.92'}, {'value': '-39.7', 'groupId': 'OG003', 'lowerLimit': '-47.37', 'upperLimit': '-32.00'}]}]}], 'analyses': [{'pValue': '0.558', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-14.03', 'ciUpperLimit': '7.59', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.295', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.8', 'ciLowerLimit': '-16.77', 'ciUpperLimit': '5.11', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.218', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.8', 'ciLowerLimit': '-17.63', 'ciUpperLimit': '4.04', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.2', 'groupId': 'OG000', 'lowerLimit': '-11.29', 'upperLimit': '-7.07'}, {'value': '-9.8', 'groupId': 'OG001', 'lowerLimit': '-11.90', 'upperLimit': '-7.75'}, {'value': '-11.9', 'groupId': 'OG002', 'lowerLimit': '-13.99', 'upperLimit': '-9.76'}, {'value': '-11.6', 'groupId': 'OG003', 'lowerLimit': '-13.65', 'upperLimit': '-9.51'}]}]}], 'analyses': [{'pValue': '0.664', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-3.58', 'ciUpperLimit': '2.28', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.075', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-5.67', 'ciUpperLimit': '0.28', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.107', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-5.33', 'ciUpperLimit': '0.52', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to Treat population: all subjects who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'groupId': 'OG000', 'lowerLimit': '-12.24', 'upperLimit': '-7.68'}, {'value': '-11.0', 'groupId': 'OG001', 'lowerLimit': '-13.29', 'upperLimit': '-8.80'}, {'value': '-12.1', 'groupId': 'OG002', 'lowerLimit': '-14.42', 'upperLimit': '-9.84'}, {'value': '-12.2', 'groupId': 'OG003', 'lowerLimit': '-14.49', 'upperLimit': '-10.0'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-4.26', 'ciUpperLimit': '2.08', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.186', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-5.39', 'ciUpperLimit': '1.05', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.157', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-5.46', 'ciUpperLimit': '0.88', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.24', 'upperLimit': '0.43'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.65'}, {'value': '-0.0', 'groupId': 'OG002', 'lowerLimit': '-0.37', 'upperLimit': '0.29'}, {'value': '0.1', 'groupId': 'OG003', 'lowerLimit': '-0.22', 'upperLimit': '0.43'}]}]}], 'analyses': [{'pValue': '0.319', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.69', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.564', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.33', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.966', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.47', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'BMLs in 15 regions were measured with MRI, and graded as 0 (normal), 1 (mild; \\< 25% of region), 2 (moderate; 25% - 50% of region), or 3 (severe; \\> 50% of region). The global total BML score was the sum of the 15 component scores, and ranged from 0 (normal) to 45 (severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.34', 'upperLimit': '0.48'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.16', 'upperLimit': '0.60'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '-0.30', 'upperLimit': '0.48'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-0.36', 'upperLimit': '0.39'}]}]}], 'analyses': [{'pValue': '0.602', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.7', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.953', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.58', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.83', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.49', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'BMLs in 15 regions were measured with MRI, and graded as 0 (normal), 1 (mild; \\< 25% of region), 2 (moderate; 25% - 50% of region), or 3 (severe; \\> 50% of region). The global total BML score was the sum of the 15 component scores, and ranged from 0 (normal) to 45 (severe).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'title': 'Intermittent Pain', 'categories': [{'measurements': [{'value': '-20.2', 'groupId': 'OG000', 'lowerLimit': '-24.32', 'upperLimit': '-16.08'}, {'value': '-19.5', 'groupId': 'OG001', 'lowerLimit': '-23.40', 'upperLimit': '-15.58'}, {'value': '-21.3', 'groupId': 'OG002', 'lowerLimit': '-25.40', 'upperLimit': '-17.26'}, {'value': '-18.8', 'groupId': 'OG003', 'lowerLimit': '-22.92', 'upperLimit': '-14.71'}]}]}, {'title': 'Constant Pain', 'categories': [{'measurements': [{'value': '-18.6', 'groupId': 'OG000', 'lowerLimit': '-22.88', 'upperLimit': '-14.33'}, {'value': '-17.7', 'groupId': 'OG001', 'lowerLimit': '-21.73', 'upperLimit': '-13.62'}, {'value': '-24.2', 'groupId': 'OG002', 'lowerLimit': '-28.39', 'upperLimit': '-19.94'}, {'value': '-20.0', 'groupId': 'OG003', 'lowerLimit': '-24.24', 'upperLimit': '-15.72'}]}]}], 'analyses': [{'pValue': '0.804', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-4.91', 'ciUpperLimit': '6.33', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Intermittent pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.699', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '4.63', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Intermittent pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.636', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-4.37', 'ciUpperLimit': '7.14', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Intermittent pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.756', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-4.91', 'ciUpperLimit': '6.76', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Constant pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.068', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.6', 'ciLowerLimit': '-11.55', 'ciUpperLimit': '0.42', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Constant pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.649', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-7.34', 'ciUpperLimit': '4.58', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Constant pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all subjects who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Index Knee ICOAP Scores at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'title': 'Intermittent Pain', 'categories': [{'measurements': [{'value': '-18.7', 'groupId': 'OG000', 'lowerLimit': '-23.21', 'upperLimit': '-14.21'}, {'value': '-19.7', 'groupId': 'OG001', 'lowerLimit': '-23.99', 'upperLimit': '-15.42'}, {'value': '-21.3', 'groupId': 'OG002', 'lowerLimit': '-25.66', 'upperLimit': '-16.98'}, {'value': '-21.7', 'groupId': 'OG003', 'lowerLimit': '-26.11', 'upperLimit': '-17.38'}]}]}, {'title': 'Constant Pain', 'categories': [{'measurements': [{'value': '-19.6', 'groupId': 'OG000', 'lowerLimit': '-24.22', 'upperLimit': '-14.96'}, {'value': '-18.8', 'groupId': 'OG001', 'lowerLimit': '-23.26', 'upperLimit': '-14.42'}, {'value': '-21.6', 'groupId': 'OG002', 'lowerLimit': '-26.05', 'upperLimit': '-17.08'}, {'value': '-22.1', 'groupId': 'OG003', 'lowerLimit': '-26.61', 'upperLimit': '-17.61'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-7.14', 'ciUpperLimit': '5.14', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Intermittent pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.409', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-8.82', 'ciUpperLimit': '3.6', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Intermittent pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.338', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3', 'ciLowerLimit': '-9.24', 'ciUpperLimit': '3.18', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Intermittent pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.817', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-5.59', 'ciUpperLimit': '7.08', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Constant pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.544', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-8.37', 'ciUpperLimit': '4.43', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Constant pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.437', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-8.91', 'ciUpperLimit': '3.86', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Constant pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all subjects who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Index Knee ICOAP Scores at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'title': 'Intermittent Pain', 'categories': [{'measurements': [{'value': '-23.2', 'groupId': 'OG000', 'lowerLimit': '-28.51', 'upperLimit': '-17.83'}, {'value': '-25.4', 'groupId': 'OG001', 'lowerLimit': '-30.21', 'upperLimit': '-20.51'}, {'value': '-23.6', 'groupId': 'OG002', 'lowerLimit': '-28.53', 'upperLimit': '-18.64'}, {'value': '-27.2', 'groupId': 'OG003', 'lowerLimit': '-32.19', 'upperLimit': '-22.14'}]}]}, {'title': 'Constant Pain', 'categories': [{'measurements': [{'value': '-20.6', 'groupId': 'OG000', 'lowerLimit': '-25.93', 'upperLimit': '-15.21'}, {'value': '-21.8', 'groupId': 'OG001', 'lowerLimit': '-26.70', 'upperLimit': '-16.94'}, {'value': '-25.2', 'groupId': 'OG002', 'lowerLimit': '-30.14', 'upperLimit': '-20.17'}, {'value': '-29.7', 'groupId': 'OG003', 'lowerLimit': '-34.78', 'upperLimit': '-24.66'}]}]}], 'analyses': [{'pValue': '0.545', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-9.31', 'ciUpperLimit': '4.92', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Intermittent pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.909', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-7.65', 'ciUpperLimit': '6.81', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Intermittent pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.278', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.0', 'ciLowerLimit': '-11.23', 'ciUpperLimit': '3.25', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Intermittent pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.732', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-8.42', 'ciUpperLimit': '5.92', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Constant pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.216', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-11.86', 'ciUpperLimit': '2.69', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Constant pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.2', 'ciLowerLimit': '-16.42', 'ciUpperLimit': '-1.88', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Constant pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Index Knee Pain Intensity at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'title': '7-Day Recall Period', 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-2.86', 'upperLimit': '-1.97'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-2.79', 'upperLimit': '-1.95'}, {'value': '-2.7', 'groupId': 'OG002', 'lowerLimit': '-3.09', 'upperLimit': '-2.22'}, {'value': '-2.1', 'groupId': 'OG003', 'lowerLimit': '-2.55', 'upperLimit': '-1.67'}]}]}, {'title': 'Activity Pain', 'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-2.85', 'upperLimit': '-1.82'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-2.85', 'upperLimit': '-1.87'}, {'value': '-2.7', 'groupId': 'OG002', 'lowerLimit': '-3.19', 'upperLimit': '-2.17'}, {'value': '-2.1', 'groupId': 'OG003', 'lowerLimit': '-2.59', 'upperLimit': '-1.56'}]}]}, {'title': 'Performance Pain (Before)', 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-2.82', 'upperLimit': '-1.89'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-2.58', 'upperLimit': '-1.70'}, {'value': '-2.5', 'groupId': 'OG002', 'lowerLimit': '-2.97', 'upperLimit': '-2.06'}, {'value': '-2.1', 'groupId': 'OG003', 'lowerLimit': '-2.52', 'upperLimit': '-1.60'}]}]}, {'title': 'Performance Pain (After)', 'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-3.07', 'upperLimit': '-2.11'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-2.90', 'upperLimit': '-2.00'}, {'value': '-2.7', 'groupId': 'OG002', 'lowerLimit': '-3.16', 'upperLimit': '-2.22'}, {'value': '-2.3', 'groupId': 'OG003', 'lowerLimit': '-2.77', 'upperLimit': '-1.82'}]}]}], 'analyses': [{'pValue': '0.874', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.66', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': '7-day recall period', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.451', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.38', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': '7-day recall period', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.331', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.93', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': '7-day recall period', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.932', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.67', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Activity pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.344', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '0.37', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Activity pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.489', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.97', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Activity pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.498', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.85', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (before)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.637', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.49', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (before)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.367', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.94', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (before)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.79', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (after)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.776', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '0.57', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (after)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.387', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.96', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (after)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': "The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Index Knee Pain Intensity at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'title': '7-Day Recall Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-2.76', 'upperLimit': '-1.73'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-2.89', 'upperLimit': '-1.91'}, {'value': '-2.8', 'groupId': 'OG002', 'lowerLimit': '-3.29', 'upperLimit': '-2.31'}, {'value': '-2.5', 'groupId': 'OG003', 'lowerLimit': '-2.98', 'upperLimit': '-1.99'}]}]}, {'title': 'Activity Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3.07', 'upperLimit': '-1.91'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-3.10', 'upperLimit': '-1.99'}, {'value': '-2.8', 'groupId': 'OG002', 'lowerLimit': '-3.37', 'upperLimit': '-2.25'}, {'value': '-2.5', 'groupId': 'OG003', 'lowerLimit': '-3.10', 'upperLimit': '-1.97'}]}]}, {'title': 'Performance Pain (Before)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-2.72', 'upperLimit': '-1.70'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-2.68', 'upperLimit': '-1.71'}, {'value': '-2.6', 'groupId': 'OG002', 'lowerLimit': '-3.13', 'upperLimit': '-2.16'}, {'value': '-2.7', 'groupId': 'OG003', 'lowerLimit': '-3.15', 'upperLimit': '-2.17'}]}]}, {'title': 'Performance Pain (After)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3.01', 'upperLimit': '-1.98'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-2.90', 'upperLimit': '-1.92'}, {'value': '-3.0', 'groupId': 'OG002', 'lowerLimit': '-3.53', 'upperLimit': '-2.54'}, {'value': '-2.6', 'groupId': 'OG003', 'lowerLimit': '-3.13', 'upperLimit': '-2.13'}]}]}], 'analyses': [{'pValue': '0.661', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.54', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': '7-day recall period', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.122', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.26', 'ciUpperLimit': '0.15', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': '7-day recall period', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.507', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.47', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': '7-day recall period', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.892', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.74', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Activity pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.433', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '0.48', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Activity pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.92', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '0.76', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Activity pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.957', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.71', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (before)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.222', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.13', 'ciUpperLimit': '0.26', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (before)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.209', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.25', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (before)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.813', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.79', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (after)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.135', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '0.17', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (after)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.679', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.57', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (after)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': "The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline In Index Knee Pain Intensity at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'title': '7-Day Recall Period', 'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-3.51', 'upperLimit': '-2.35'}, {'value': '-2.9', 'groupId': 'OG001', 'lowerLimit': '-3.45', 'upperLimit': '-2.39'}, {'value': '-2.9', 'groupId': 'OG002', 'lowerLimit': '-3.43', 'upperLimit': '-2.35'}, {'value': '-3.1', 'groupId': 'OG003', 'lowerLimit': '-3.65', 'upperLimit': '-2.56'}]}]}, {'title': 'Activity Pain', 'categories': [{'measurements': [{'value': '-2.8', 'groupId': 'OG000', 'lowerLimit': '-3.48', 'upperLimit': '-2.16'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-3.64', 'upperLimit': '-2.43'}, {'value': '-3.2', 'groupId': 'OG002', 'lowerLimit': '-3.77', 'upperLimit': '-2.55'}, {'value': '-3.0', 'groupId': 'OG003', 'lowerLimit': '-3.65', 'upperLimit': '-2.40'}]}]}, {'title': 'Performance Pain (Before)', 'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-3.14', 'upperLimit': '-2.03'}, {'value': '-2.7', 'groupId': 'OG001', 'lowerLimit': '-3.24', 'upperLimit': '-2.23'}, {'value': '-3.0', 'groupId': 'OG002', 'lowerLimit': '-3.51', 'upperLimit': '-2.49'}, {'value': '-2.9', 'groupId': 'OG003', 'lowerLimit': '-3.46', 'upperLimit': '-2.41'}]}]}, {'title': 'Performance Pain (After)', 'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-3.47', 'upperLimit': '-2.33'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-3.53', 'upperLimit': '-2.50'}, {'value': '-3.4', 'groupId': 'OG002', 'lowerLimit': '-3.90', 'upperLimit': '-2.86'}, {'value': '-3.2', 'groupId': 'OG003', 'lowerLimit': '-3.69', 'upperLimit': '-2.62'}]}]}], 'analyses': [{'pValue': '0.978', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '0.79', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': '7-day recall period', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.925', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.82', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': '7-day recall period', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.659', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '0.61', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': '7-day recall period', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.67', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Activity pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.46', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.23', 'ciUpperLimit': '0.56', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Activity pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.663', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.7', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Activity pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.696', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '0.59', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (before)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.278', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.34', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (before)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.357', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.4', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (before)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.761', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.64', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (after)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.218', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '0.51', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.513', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.02', 'ciUpperLimit': '0.51', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Performance pain (after)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-2.94', 'upperLimit': '-2.01'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-2.80', 'upperLimit': '-1.92'}, {'value': '-2.9', 'groupId': 'OG002', 'lowerLimit': '-3.34', 'upperLimit': '-2.42'}, {'value': '-2.6', 'groupId': 'OG003', 'lowerLimit': '-3.08', 'upperLimit': '-2.15'}]}]}], 'analyses': [{'pValue': '0.728', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.75', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.219', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.24', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.673', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.51', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PGA of Arthritis of the Index Knee at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-2.96', 'upperLimit': '-1.91'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-2.94', 'upperLimit': '-1.94'}, {'value': '-3.0', 'groupId': 'OG002', 'lowerLimit': '-3.48', 'upperLimit': '-2.47'}, {'value': '-2.7', 'groupId': 'OG003', 'lowerLimit': '-3.18', 'upperLimit': '-2.16'}]}]}], 'analyses': [{'pValue': '0.984', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.71', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.145', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.26', 'ciUpperLimit': '0.19', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.527', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '0.49', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PGA of Arthritis of the Index Knee at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-3.62', 'upperLimit': '-2.44'}, {'value': '-2.9', 'groupId': 'OG001', 'lowerLimit': '-3.48', 'upperLimit': '-2.41'}, {'value': '-3.2', 'groupId': 'OG002', 'lowerLimit': '-3.71', 'upperLimit': '-2.62'}, {'value': '-3.5', 'groupId': 'OG003', 'lowerLimit': '-4.01', 'upperLimit': '-2.89'}]}]}], 'analyses': [{'pValue': '0.836', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.87', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.738', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.66', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '0.38', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cartilage Volume of the Index Knee at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'title': 'Global Knee', 'categories': [{'measurements': [{'value': '-326.0', 'groupId': 'OG000', 'lowerLimit': '-400.83', 'upperLimit': '-251.13'}, {'value': '-325.5', 'groupId': 'OG001', 'lowerLimit': '-397.10', 'upperLimit': '-253.83'}, {'value': '-322.4', 'groupId': 'OG002', 'lowerLimit': '-400.20', 'upperLimit': '-244.61'}, {'value': '-359.0', 'groupId': 'OG003', 'lowerLimit': '-429.72', 'upperLimit': '-288.35'}]}]}, {'title': 'Medial Central Condyle + Plateau', 'categories': [{'measurements': [{'value': '-59.1', 'groupId': 'OG000', 'lowerLimit': '-83.12', 'upperLimit': '-35.10'}, {'value': '-54.9', 'groupId': 'OG001', 'lowerLimit': '-77.83', 'upperLimit': '-31.90'}, {'value': '-50.1', 'groupId': 'OG002', 'lowerLimit': '-75.13', 'upperLimit': '-25.07'}, {'value': '-57.5', 'groupId': 'OG003', 'lowerLimit': '-80.12', 'upperLimit': '-34.88'}]}]}, {'title': 'Medial Condyle + Plateau', 'categories': [{'measurements': [{'value': '-128.6', 'groupId': 'OG000', 'lowerLimit': '-166.76', 'upperLimit': '-90.50'}, {'value': '-126.5', 'groupId': 'OG001', 'lowerLimit': '-163.03', 'upperLimit': '-90.02'}, {'value': '-124.5', 'groupId': 'OG002', 'lowerLimit': '-164.13', 'upperLimit': '-84.86'}, {'value': '-114.9', 'groupId': 'OG003', 'lowerLimit': '-150.86', 'upperLimit': '-78.90'}]}]}], 'analyses': [{'pValue': '0.992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-101.59', 'ciUpperLimit': '102.62', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Global knee', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.948', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '-103.95', 'ciUpperLimit': '111.10', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Global knee', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.523', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.1', 'ciLowerLimit': '-134.76', 'ciUpperLimit': '68.65', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Global knee', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.799', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '-28.47', 'ciUpperLimit': '36.95', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Medial central condyle + plateau', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.609', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.0', 'ciLowerLimit': '-25.62', 'ciUpperLimit': '43.64', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Medial central condyle + plateau', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.923', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-30.97', 'ciUpperLimit': '34.19', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Medial central condyle + plateau', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.937', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-49.88', 'ciUpperLimit': '54.08', 'pValueComment': 'P-value for test of difference 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at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Medial central condyle + plateau', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.413', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.012', 'ciLowerLimit': '-0.041', 'ciUpperLimit': '0.017', 'pValueComment': 'P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Medial condyle + plateau', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.445', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.012', 'ciLowerLimit': '-0.018', 'ciUpperLimit': '0.042', 'pValueComment': 'P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Medial condyle + plateau', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.835', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.003', 'ciLowerLimit': '-0.032', 'ciUpperLimit': '0.026', 'pValueComment': 'P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.', 'groupDescription': 'Medial condyle + plateau', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Cartilage thickness of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.', 'unitOfMeasure': 'mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.'}, {'type': 'SECONDARY', 'title': 'Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '49.6', 'upperLimit': '70.4'}, {'value': '67.0', 'groupId': 'OG001', 'lowerLimit': '57.2', 'upperLimit': '76.9'}, {'value': '72.6', 'groupId': 'OG002', 'lowerLimit': '63.1', 'upperLimit': '82.2'}, {'value': '65.5', 'groupId': 'OG003', 'lowerLimit': '55.5', 'upperLimit': '75.5'}]}]}], 'analyses': [{'pValue': '0.311', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.0', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '21.4', 'pValueComment': 'P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.435', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '-8.9', 'ciUpperLimit': '19.9', 'pValueComment': 'P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.435', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '-8.9', 'ciUpperLimit': '19.9', 'pValueComment': 'P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Percentage of participants classified as OMERACT-OARSI responders at Week 16. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF.'}, {'type': 'SECONDARY', 'title': 'Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'groupId': 'OG000', 'lowerLimit': '52.1', 'upperLimit': '72.7'}, {'value': '64.8', 'groupId': 'OG001', 'lowerLimit': '54.8', 'upperLimit': '74.8'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '56.6', 'upperLimit': '76.7'}, {'value': '72.7', 'groupId': 'OG003', 'lowerLimit': '63.4', 'upperLimit': '82.0'}]}]}], 'analyses': [{'pValue': '0.744', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-11.9', 'ciUpperLimit': '16.8', 'pValueComment': 'P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.581', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-10.1', 'ciUpperLimit': '18.7', 'pValueComment': 'P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.146', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.4', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '24.3', 'pValueComment': 'P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Percentage of participants classified as OMERACT-OARSI responders at Week 26. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF.'}, {'type': 'SECONDARY', 'title': 'Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'OG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'OG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'OG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '60.9', 'upperLimit': '80.3'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '59.7', 'upperLimit': '79.0'}, {'value': '71.4', 'groupId': 'OG002', 'lowerLimit': '61.8', 'upperLimit': '81.1'}, {'value': '72.7', 'groupId': 'OG003', 'lowerLimit': '63.4', 'upperLimit': '82.0'}]}]}], 'analyses': [{'pValue': '0.824', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-14.9', 'ciUpperLimit': '12.4', 'pValueComment': 'P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.964', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-12.8', 'ciUpperLimit': '14.5', 'pValueComment': 'P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.763', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-11.3', 'ciUpperLimit': '15.6', 'pValueComment': 'P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Percentage of participants classified as OMERACT-OARSI responders at Week 52. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'FG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'FG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'FG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Did Not Receive Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'The study included a screening period (approximately 45 days prior to first study drug dose) and a washout period (5 half-lives of the longest acting analgesic used, or 48 hours, whichever was longer, in which all standard of care analgesic medications were discontinued prior to the first study drug dose).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '347', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matching placebo SC E2W'}, {'id': 'BG001', 'title': 'ABT-981 25 mg', 'description': '25 mg ABT-981 SC E2W'}, {'id': 'BG002', 'title': 'ABT-981 100 mg', 'description': '100 mg ABT-981 SC E2W'}, {'id': 'BG003', 'title': 'ABT-981 200 mg', 'description': '200 mg ABT-981 SC E2W'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.53', 'spread': '8.850', 'groupId': 'BG000'}, {'value': '61.63', 'spread': '7.546', 'groupId': 'BG001'}, {'value': '60.21', 'spread': '8.194', 'groupId': 'BG002'}, {'value': '59.05', 'spread': '10.273', 'groupId': 'BG003'}, {'value': '60.11', 'spread': '8.792', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '225', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified intent-to-treat population: all participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2017-08-25', 'completionDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2014-03-13', 'dispFirstSubmitQcDate': '2017-08-25', 'resultsFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2014-03-13', 'dispFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-09', 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Change in synovitis of the index knee was evaluated using quantitative magnetic resonance imaging (MRI) measurements. MRI quantitative synovitis of the index knee was defined by mean synovial membrane thickness.'}, {'measure': 'Change From Baseline in Effusion Volume of the Index Knee at Week 26', 'timeFrame': 'Baseline, Week 26'}, {'measure': 'Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Semi-quantitative synovitis/effusion volume WORMS scores were scored as normal (0), \\< 33% of maximum estimated distention (1), 33% - 66% of maximum estimated distention (2), or \\> 66% of maximum estimated distention (3).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'BMLs in 15 regions were measured with MRI, and graded as 0 (normal), 1 (mild; \\< 25% of region), 2 (moderate; 25% - 50% of region), or 3 (severe; \\> 50% of region). The global total BML score was the sum of the 15 component scores, and ranged from 0 (normal) to 45 (severe).'}, {'measure': 'Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'BMLs in 15 regions were measured with MRI, and graded as 0 (normal), 1 (mild; \\< 25% of region), 2 (moderate; 25% - 50% of region), or 3 (severe; \\> 50% of region). The global total BML score was the sum of the 15 component scores, and ranged from 0 (normal) to 45 (severe).'}, {'measure': 'Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).'}, {'measure': 'Change From Baseline in Index Knee ICOAP Scores at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).'}, {'measure': 'Change From Baseline in Index Knee ICOAP Scores at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).'}, {'measure': 'Change From Baseline In Index Knee Pain Intensity at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': "The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded."}, {'measure': 'Change From Baseline In Index Knee Pain Intensity at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': "The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded."}, {'measure': 'Change From Baseline In Index Knee Pain Intensity at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded."}, {'measure': 'Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.'}, {'measure': 'Change From Baseline in PGA of Arthritis of the Index Knee at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.'}, {'measure': 'Change From Baseline in PGA of Arthritis of the Index Knee at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.'}, {'measure': 'Change From Baseline in Cartilage Volume of the Index Knee at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Cartilage volume of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.'}, {'measure': 'Change From Baseline in Cartilage Volume of the Index Knee at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Cartilage volume of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.'}, {'measure': 'Change From Baseline in Cartilage Thickness of the Index Knee at Week 26', 'timeFrame': 'Baseline, Week 26', 'description': 'Cartilage thickness of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.'}, {'measure': 'Change From Baseline in Cartilage Thickness of the Index Knee at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Cartilage thickness of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.'}, {'measure': 'Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16', 'timeFrame': 'Week 16', 'description': 'Percentage of participants classified as OMERACT-OARSI responders at Week 16. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.'}, {'measure': 'Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26', 'timeFrame': 'Week 26', 'description': 'Percentage of participants classified as OMERACT-OARSI responders at Week 26. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.'}, {'measure': 'Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52', 'timeFrame': 'Week 52', 'description': 'Percentage of participants classified as OMERACT-OARSI responders at Week 52. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Synovitis', 'Knee', 'Pain'], 'conditions': ['Knee Osteoarthritis', 'Medial Compartment Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '30653843', 'type': 'DERIVED', 'citation': 'Fleischmann RM, Bliddal H, Blanco FJ, Schnitzer TJ, Peterfy C, Chen S, Wang L, Feng S, Conaghan PG, Berenbaum F, Pelletier JP, Martel-Pelletier J, Vaeterlein O, Kaeley GS, Liu W, Kosloski MP, Levy G, Zhang L, Medema JK, Levesque MC. A Phase II Trial of Lutikizumab, an Anti-Interleukin-1alpha/beta Dual Variable Domain Immunoglobulin, in Knee Osteoarthritis Patients With Synovitis. Arthritis Rheumatol. 2019 Jul;71(7):1056-1069. doi: 10.1002/art.40840. Epub 2019 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Radiographic knee osteoarthritis with Kellgren-Lawrence Grade 2 or 3\n2. Body Mass Index (BMI) 18-34 kg/m2\n3. One or more clinical signs and symptoms of active inflammation in the index knee\n\nExclusion Criteria:\n\n1. History of allergic reaction to any constituents of the study drug, or to any Immunoglobulin G (IgG)-containing product\n2. History of anaphylactic reaction to any agent\n3. Significant trauma or surgery to the index knee\n4. Severe knee malalignment\n5. Any uncontrolled medical illness or an unstable treatment or therapy'}, 'identificationModule': {'nctId': 'NCT02087904', 'briefTitle': 'A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'M13-741'}, 'secondaryIdInfos': [{'id': '2013-003467-60', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABT-981 low dose', 'description': '25 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W)', 'interventionNames': ['Biological: ABT-981']}, {'type': 'EXPERIMENTAL', 'label': 'ABT-981 medium dose', 'description': '100 mg ABT-981 SC E2W', 'interventionNames': ['Biological: ABT-981']}, {'type': 'EXPERIMENTAL', 'label': 'ABT-981 high dose', 'description': '200 mg ABT-981 SC E2W', 'interventionNames': ['Biological: ABT-981']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'ABT-981', 'type': 'BIOLOGICAL', 'otherNames': ['Lutikizumab'], 'armGroupLabels': ['ABT-981 high dose', 'ABT-981 low dose', 'ABT-981 medium dose']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marc Levesque, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}