Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-28 @ 12:01 AM
Study NCT ID:
NCT01023256
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2009-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599766', 'term': 'Otilimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Roman.Korolkiewicz@morphosys.com', 'phone': '+498989927', 'title': 'Roman Korolkiewicz', 'phoneExt': '208', 'organization': 'MorphoSys'}, 'certainAgreement': {'otherDetails': "All information supplied by MorphoSys is considered confidential until publication and shall not be disclosed without prior written consent from MorphoSys. No data can be published in any format without prior approval of the MSC-1001 Publication Committee, which has final decision on approving submissions for publication. In the event of disagreement in the content of a publication, both the Author's and MorphoSys' opinion will be fairly and sufficiently represented in the publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Key limitations of this trial include its small sample size, limited duration, and exclusion of patients with severe rheumatoid arthritis. Larger clinical trials are needed to confirm these data and define the optimal MOR103 dosage.'}}, 'adverseEventsModule': {'timeFrame': 'All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.', 'eventGroups': [{'id': 'EG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)', 'otherNumAtRisk': 24, 'otherNumAffected': 11, 'seriousNumAtRisk': 24, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)', 'otherNumAtRisk': 22, 'otherNumAffected': 22, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)', 'otherNumAtRisk': 23, 'otherNumAffected': 14, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Pooled Active', 'description': 'All patients receiving MOR103 at any dose', 'otherNumAtRisk': 69, 'otherNumAffected': 47, 'seriousNumAtRisk': 69, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Pooled Placebo', 'description': 'Pooled placebo group included all patients who were randomized to placebo in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)', 'otherNumAtRisk': 27, 'otherNumAffected': 12, 'seriousNumAtRisk': 27, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Viral respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rheumatoid arthritis', 'notes': 'Worsening or flares of rheumatoid arthritis. In 8 of the 9 MOR103 subjects with RA exacerbations, this AE occurred after the last dose of MOR103 (10 days to \\>12 weeks), suggesting that disease flares were related to withdrawal of active treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Carbon monoxide diffusing capacity decreased', 'notes': 'Based on investigator reports of clinically relevant events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'notes': 'Includes patients with preferred term "rash" and preferred term "rash maculo-papular"', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentages of Patients With Treatment-emergent or Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG003', 'title': 'Pooled Active', 'description': 'All patients receiving MOR103 at any dose'}, {'id': 'OG004', 'title': 'Pooled Placebo', 'description': 'All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).'}], 'classes': [{'title': 'Percentage with treatment-emergent adverse events', 'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000'}, {'value': '63.6', 'groupId': 'OG001'}, {'value': '65.2', 'groupId': 'OG002'}, {'value': '60.9', 'groupId': 'OG003'}, {'value': '44.4', 'groupId': 'OG004'}]}]}, {'title': 'Percentage with serious adverse events', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '1.4', 'groupId': 'OG003'}, {'value': '3.7', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose through the 16-week visit', 'description': 'Data on treatment-emergent adverse events (MedDRA version 13.0) were collected at each visit (weeks 1, 2, 3, 4, 5, 6, 8, 10, 13, and 16). For a list of serious adverse events and adverse events occurring at a frequency of \\>5 % (\\>1 patient) in any treatment group, please see the adverse events listing.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who received treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.7', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.095', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \\< 0.05 were considered significant.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \\< 0.05 were considered significant.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \\< 0.05 were considered significant.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to week 4 (1 week after last MOR103 dose)', 'description': 'The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.37', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '2.87', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '2.22', 'groupId': 'OG002'}, {'value': '-0.66', 'spread': '3.09', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from screening to week 4 (1 week after last MOR103 dose)', 'description': 'Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At week 4, MRI data were not available for 5 placebo patients, 2 MOR103 0.3 mg/kg patients, 2 MOR103 1.0 mg/kg patients, and 1 MOR103 1.5 mg/kg patient.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.9', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.421', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \\< 0.05 were considered significant.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \\< 0.05 were considered significant.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.', 'testedNonInferiority': False}, {'pValue': '0.065', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \\< 0.05 were considered significant.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to week 8 (5 weeks after last MOR103 dose)', 'description': 'The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '68.2', 'groupId': 'OG001'}, {'value': '30.4', 'groupId': 'OG002'}, {'value': '7.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.243', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'P values \\<0.05 were considered to be statistically significant.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Patients with missing values were not included', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'P values \\< 0.05 were considered significant.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Patients with missing values were not included', 'testedNonInferiority': False}, {'pValue': '0.135', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'P values \\<0.05 were considered to be statistically significant.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Patients with missing values were not included.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 (1 week after last MOR103 dose)', 'description': 'The percentage of patients achieving an ACR20 response (20% improvement based on ACR improvement criteria) in each group. ACR20 improvement criteria require at least 20% improvement in both swollen and tender joints counts and 3 out of 5 of the following parameters: pain visual analog scale, patient global assessment, physician global assessment, acute phase reactant (erythrocyte sedimentation rate or C-reactive protein), and functional questionnaire.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were included in ACR response calculations. Patients lacking data required for calculation of an ACR response were considered as not having an ACR response. 1 patient in the MOR103 0.3 mg/kg group, 1 patient in the MOR103 1.0 mg/kg group, and 5 patients in the pooled placebo group had missing data for ACR calculations.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).'}], 'classes': [{'title': 'Change in swollen joint count at week 4', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '3.2', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '3.5', 'groupId': 'OG003'}]}]}, {'title': 'Change in swollen joint count at week 8', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '3.1', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'Change in tender joint count at week 4', 'categories': [{'measurements': [{'value': '0.1', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': '6.2', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '6.4', 'groupId': 'OG003'}]}]}, {'title': 'Change in tender joint count at week 8', 'categories': [{'measurements': [{'value': '0.3', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '5.3', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '8.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8', 'description': 'Swollen joint counts were based on 66 joints and tender joint counts were based on 69 joints.', 'unitOfMeasure': 'joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).'}], 'classes': [{'title': 'Change in pain at week 4', 'categories': [{'measurements': [{'value': '-8.6', 'spread': '22.8', 'groupId': 'OG000'}, {'value': '-17.4', 'spread': '17.2', 'groupId': 'OG001'}, {'value': '-11.4', 'spread': '11.5', 'groupId': 'OG002'}, {'value': '-3.3', 'spread': '16.5', 'groupId': 'OG003'}]}]}, {'title': 'Change in pain at week 8', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '-13.4', 'spread': '20.9', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '11.9', 'groupId': 'OG002'}, {'value': '-8.0', 'spread': '16.1', 'groupId': 'OG003'}]}]}, {'title': 'Change in HAQ-DI at week 4', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '-0.31', 'spread': '0.24', 'groupId': 'OG002'}, {'value': '-0.45', 'spread': '0.54', 'groupId': 'OG003'}]}]}, {'title': 'Change in HAQ-DI at week 8', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '-0.25', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '-0.44', 'spread': '0.54', 'groupId': 'OG003'}]}]}, {'title': 'Change in patient global assessment at week 4', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '17.7', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '16.1', 'groupId': 'OG003'}]}]}, {'title': 'Change in patient global assessment at week 8', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '24.7', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '8.3', 'groupId': 'OG002'}, {'value': '-8.2', 'spread': '17.5', 'groupId': 'OG003'}]}]}, {'title': 'Change in FACIT fatigue score at week 4', 'categories': [{'measurements': [{'value': '2.7', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '10.2', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '6.0', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '8.1', 'groupId': 'OG003'}]}]}, {'title': 'Change in FACIT fatigue score at week 8', 'categories': [{'measurements': [{'value': '2.1', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '7.1', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '9.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8', 'description': "Patient-reported outcomes included patient's self-assessment of pain (measured on a 100 mm visual analogue scale \\[VAS\\] from 0 = best to 100 = worst), the Health Assessment Questionnaire-Disability Index (HAQ-DI; 0 = best to 3 = worst), the patient's global assessment of disease activity (measured on a 100 mm visual analogue scale \\[VAS\\] from 0 = best to 100 = worst), and fatigue, which was measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue self-assessment scale (0 = worst; 52 = best).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.48', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '2.73', 'groupId': 'OG002'}, {'value': '-0.91', 'spread': '3.06', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from screening to week 8', 'description': 'Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At week 8, MRI data were not available for 6 placebo patients, 5 MOR103 0.3 mg/kg patients, 1 MOR103 1.0 mg/kg patient, and 2 MOR103 1.5 mg/kg patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'FG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'FG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'FG003', 'title': 'Pooled Placebo', 'description': 'All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects were recruited and screened between January 19, 2010 and February 9, 2012 at rheumatology centers in Europe (Bulgaria, Germany, the Netherlands, Poland and Ukraine).', 'preAssignmentDetails': 'Subject eligibility was determined at the screening visit (up to 35 days before treatment initiation) and confirmed at baseline before the first dose on day 1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'MOR103 0.3 mg/kg', 'description': 'MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'BG001', 'title': 'MOR103 1.0 mg/kg', 'description': 'MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'BG002', 'title': 'MOR103 1.5 mg/kg', 'description': 'MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)'}, {'id': 'BG003', 'title': 'Pooled Placebo', 'description': 'All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '49.0', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '53.0', 'spread': '9.9', 'groupId': 'BG002'}, {'value': '53.8', 'spread': '12.7', 'groupId': 'BG003'}, {'value': '53.4', 'spread': '11.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Poland', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '26.1', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '25.7', 'spread': '4.7', 'groupId': 'BG002'}, {'value': '26.3', 'spread': '3.5', 'groupId': 'BG003'}, {'value': '26.1', 'spread': '4.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Activity Score based on 28 joints and erythrocyte sedimentation rate (DAS28-ESR)', 'classes': [{'categories': [{'measurements': [{'value': '4.88', 'spread': '0.54', 'groupId': 'BG000'}, {'value': '4.78', 'spread': '0.66', 'groupId': 'BG001'}, {'value': '4.87', 'spread': '0.38', 'groupId': 'BG002'}, {'value': '4.88', 'spread': '0.41', 'groupId': 'BG003'}, {'value': '4.86', 'spread': '0.50', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The Disease Activity Score is a measure of overall disease activity and was calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity). In the MOR103 1.0 mg/kg group, one patient had missing data so the mean was calculated on 21 patients.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rheumatoid factor (RF) status', 'classes': [{'title': 'RF positive', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}]}, {'title': 'RF negative', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Defined as RF levels \\>13.9 IU/mL. One patient in the MOR103 1.0 mg/kg group and one patient in the pooled placebo group had missing data.', 'unitOfMeasure': 'participants'}, {'title': 'Prior medication with non-biologic disease-modifying antirheumatic drugs (DMARDs)', 'classes': [{'title': 'Treated with prior non-biologic DMARDs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}]}, {'title': 'Not treated with prior non-biologic DMARDs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Medication with non-biologic disease-modifying drugs in the 3 months prior to screening', 'unitOfMeasure': 'participants'}, {'title': 'Prior medication with tumor necrosis factor (TNF) inhibitors', 'classes': [{'title': 'Treated with prior TNF inhibitors', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Not treated with prior TNF inhibitors', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Medication with tumour necrosis factor inhibitors in the 3 months prior to screening', 'unitOfMeasure': 'participants'}, {'title': 'Concomitant medication with non-biologic disease-modifying antirheumatic drugs (DMARDs)', 'classes': [{'title': 'Treated with concomitant non-biologic DMARDs', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}]}]}, {'title': 'Not treated with concomitant non-biologic DMARDs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Concomitant medication with non-biologic disease-modifying antirheumatic drugs at baseline', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All baseline participants were included in baseline analyses.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-15', 'studyFirstSubmitDate': '2009-11-19', 'resultsFirstSubmitDate': '2014-04-07', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-07', 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4', 'timeFrame': 'Change from screening to week 4 (1 week after last MOR103 dose)', 'description': 'Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.'}, {'measure': 'Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8', 'timeFrame': 'Change from screening to week 8', 'description': 'Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.'}], 'primaryOutcomes': [{'measure': 'Percentages of Patients With Treatment-emergent or Serious Adverse Events', 'timeFrame': 'From the first dose through the 16-week visit', 'description': 'Data on treatment-emergent adverse events (MedDRA version 13.0) were collected at each visit (weeks 1, 2, 3, 4, 5, 6, 8, 10, 13, and 16). For a list of serious adverse events and adverse events occurring at a frequency of \\>5 % (\\>1 patient) in any treatment group, please see the adverse events listing.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks', 'timeFrame': 'Change from baseline to week 4 (1 week after last MOR103 dose)', 'description': 'The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity).'}, {'measure': 'Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks', 'timeFrame': 'Change from baseline to week 8 (5 weeks after last MOR103 dose)', 'description': 'The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity)'}, {'measure': 'Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4', 'timeFrame': 'Week 4 (1 week after last MOR103 dose)', 'description': 'The percentage of patients achieving an ACR20 response (20% improvement based on ACR improvement criteria) in each group. ACR20 improvement criteria require at least 20% improvement in both swollen and tender joints counts and 3 out of 5 of the following parameters: pain visual analog scale, patient global assessment, physician global assessment, acute phase reactant (erythrocyte sedimentation rate or C-reactive protein), and functional questionnaire.'}, {'measure': 'Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8', 'timeFrame': 'Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8', 'description': 'Swollen joint counts were based on 66 joints and tender joint counts were based on 69 joints.'}, {'measure': 'Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8', 'timeFrame': 'Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8', 'description': "Patient-reported outcomes included patient's self-assessment of pain (measured on a 100 mm visual analogue scale \\[VAS\\] from 0 = best to 100 = worst), the Health Assessment Questionnaire-Disability Index (HAQ-DI; 0 = best to 3 = worst), the patient's global assessment of disease activity (measured on a 100 mm visual analogue scale \\[VAS\\] from 0 = best to 100 = worst), and fatigue, which was measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue self-assessment scale (0 = worst; 52 = best)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis', 'GM-CSF', 'MOR103'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '24534756', 'type': 'RESULT', 'citation': 'Behrens F, Tak PP, Ostergaard M, Stoilov R, Wiland P, Huizinga TW, Berenfus VY, Vladeva S, Rech J, Rubbert-Roth A, Korkosz M, Rekalov D, Zupanets IA, Ejbjerg BJ, Geiseler J, Fresenius J, Korolkiewicz RP, Schottelius AJ, Burkhardt H. MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial. Ann Rheum Dis. 2015 Jun;74(6):1058-64. doi: 10.1136/annrheumdis-2013-204816. Epub 2014 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.', 'detailedDescription': 'Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects 0.5% to 1% of the adult population world wide. RA primarily affects the joints and is characterized by chronic inflammation of the synovial tissue, which eventually leads to the destruction of cartilage, bone and ligaments and can cause joint deformity.\n\nPro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNFα), interleukin (IL)-1, IL-6 and granulocyte macrophage colony stimulating factor (GM-CSF), which lead to the activation and proliferation of immune cells, are found to be increased in the inflamed joint. Several preclinical findings support an anti-GM-CSF therapy for RA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatoid arthritis (RA) per revised 1987 ACR criteria\n* Active RA: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the PIP joint\n* CRP \\> 5.0 mg/L (RF and anti-CCP seronegative); CRP \\>2 mg/l (RF and/or anti-CCP seropositive)\n* DAS28 ≤ 5.1\n* Stable regimen of concomitant RA therapy (NSAIDs, steroids, non- biological DMARDs).\n* Negative PPD tuberculin skin test\n\nExclusion Criteria:\n\n* Previous therapy with B or T cell depleting agents other than Rituximab (e.g. Campath). Prior treatment with Rituximab, TNF-inhibitors, other biologics (e.g. anti-IL-1 therapy) and systemic immunosuppressive agents is allowed with a washout period.\n* Any history of ongoing, significant or recurring infections\n* Any active inflammatory diseases other than RA\n* Treatment with a systemic investigational drug within 6 months prior to screening\n* Women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide\n* Significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity)\n* Hepatic or renal insufficiency'}, 'identificationModule': {'nctId': 'NCT01023256', 'briefTitle': 'Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'MorphoSys AG'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of MOR103 Administered Intravenously to Patients With Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'MSC-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: MOR103, experimental', 'description': 'Biological: MOR103 0.3 mg/kg or placebo', 'interventionNames': ['Drug: MOR103']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: MOR103, experimental', 'description': 'Biological: MOR103 1.0 mg/kg or placebo', 'interventionNames': ['Drug: MOR103']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: MOR103, experimental', 'description': 'Biological: MOR103 1.5 mg/kg or placebo', 'interventionNames': ['Drug: MOR103']}], 'interventions': [{'name': 'MOR103', 'type': 'DRUG', 'description': 'MOR103 0.3 mg/kg or placebo iv x 4 doses', 'armGroupLabels': ['Group 1: MOR103, experimental']}, {'name': 'MOR103', 'type': 'DRUG', 'description': 'MOR103 1.0 mg/kg or placebo iv x 4 doses', 'armGroupLabels': ['Group 2: MOR103, experimental']}, {'name': 'MOR103', 'type': 'DRUG', 'description': 'MOR103 1.5 mg/kg or placebo iv x 4 doses', 'armGroupLabels': ['Group 3: MOR103, experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'MorphoSys Investigative Sites', 'country': 'Bulgaria', 'facility': 'MorphoSys Investigative sites'}, {'city': 'MorphoSys Investigative Sites', 'country': 'Germany', 'facility': 'MorphoSys Investigative sites'}, {'city': 'MorphoSys Investigative Sites', 'country': 'Netherlands', 'facility': 'MorphoSys Investigative sites'}, {'city': 'MorphoSys Investigative Sites', 'country': 'Poland', 'facility': 'MorphoSys Investigative sites'}, {'city': 'MorphoSys Investigatíve Sites', 'country': 'Ukraine', 'facility': 'MorphoSys Investigative sites'}], 'overallOfficials': [{'name': 'Roman P Korolkiewicz, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MorphoSys AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MorphoSys AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}