Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-24 @ 7:30 AM
Study NCT ID:
NCT02079532
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2014-03-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor
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': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 24 weeks of follow up.', 'description': 'Note that available data included a summary of events by system organ class only, no data provided by preferred term.', 'eventGroups': [{'id': 'EG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.', 'otherNumAtRisk': 302, 'otherNumAffected': 62, 'seriousNumAtRisk': 302, 'seriousNumAffected': 36}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ear and labyrinth disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Endocrine disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 302, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.56', 'spread': '1.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': "The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-ated rheumatoid arthritis \\[RA\\] activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\\>)3.2 to 5.1 = moderate to high disease activity.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population: all participants who signed informed consent, received at least 1 dose of study drug, and where DAS28 was measured at least once under study medication (Weeks 8, 16, or 24 or unscheduled or withdrawal visit up to Week 24); those with no RA or no DAS28 score at screening were excluded, regardless if treated or not.'}, {'type': 'SECONDARY', 'title': 'DAS28 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=291)', 'categories': [{'measurements': [{'value': '5.87', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=277)', 'categories': [{'measurements': [{'value': '4.57', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=271)', 'categories': [{'measurements': [{'value': '4.17', 'spread': '1.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=266)', 'categories': [{'measurements': [{'value': '4.30', 'spread': '1.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': "The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant-rated RA assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n (number) = number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Week 8 (n=172)', 'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=198)', 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=188)', 'categories': [{'measurements': [{'value': '64.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 16, and 24', 'description': 'The DAS28-based EULAR response criteria were used to measure individual responses as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders experienced a change from baseline of \\>1.2 with a DAS28 score ≤3.2 and moderate responders experienced a change from baseline \\>1.2 with DAS28 \\>3.2 to ≤5.1 or a change from baseline \\>0.6 to ≤1.2 with a DAS28 score of ≤5.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "Percentage of participants with low disease activity defined as DAS28 ≤3.2 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "Percentage of participants with remission defined as DAS28 \\<2.6 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Response By EULAR Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Moderate response, Week 8', 'categories': [{'measurements': [{'value': '45.4', 'groupId': 'OG000'}]}]}, {'title': 'Moderate response, Week 16', 'categories': [{'measurements': [{'value': '44.3', 'groupId': 'OG000'}]}]}, {'title': 'Moderate response, Week 24', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000'}]}]}, {'title': 'Good response, Week 8', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}]}]}, {'title': 'Good response, Week 16', 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000'}]}]}, {'title': 'Good response, Week 24', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}]}]}, {'title': 'No response, Week 8', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}]}]}, {'title': 'No response, Week 16', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000'}]}]}, {'title': 'No response, Week 24', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 16, and 24', 'description': "Percentage of participants achieving a response by EULAR category, including 'moderate', 'good', or no response at follow-up Weeks 8, 16, and 24. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \\>1.2 with a DAS28 score ≤ 3.2; moderate responders had a change from baseline \\>1.2 with a DAS28 score of \\>3.2 to ≤5.1 or a change from baseline \\>0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline \\>0.6 and ≤1.2 with a DAS28 score of \\>5.1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire - Disability Index (HAQ-DI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=288)', 'categories': [{'measurements': [{'value': '1.60', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=286)', 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=276)', 'categories': [{'measurements': [{'value': '1.33', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=269)', 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=286)', 'categories': [{'measurements': [{'value': '23.81', 'spread': '11.35', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=282)', 'categories': [{'measurements': [{'value': '20.87', 'spread': '11.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=272)', 'categories': [{'measurements': [{'value': '18.92', 'spread': '11.46', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=262)', 'categories': [{'measurements': [{'value': '18.53', 'spread': '11.48', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The FACIT fatigue scale is base on a 13-item questionnaire to assess the therapy-induced fatigue. Participants were requested to score each question on a scale ranging from 0 (best) to 4 (worst). The scoring system of the FACIT fatigue scale adds up to a total scale ranging from 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': 'Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'PCS, Screening (n=287)', 'categories': [{'measurements': [{'value': '30.97', 'spread': '8.14', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Week 8 (n=279)', 'categories': [{'measurements': [{'value': '34.24', 'spread': '8.56', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Week 16 (n=270)', 'categories': [{'measurements': [{'value': '35.92', 'spread': '8.43', 'groupId': 'OG000'}]}]}, {'title': 'PCS, Week 24 (n=264)', 'categories': [{'measurements': [{'value': '36.36', 'spread': '9.00', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Screening (n=287)', 'categories': [{'measurements': [{'value': '40.88', 'spread': '13.16', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Week 8 (n=279)', 'categories': [{'measurements': [{'value': '43.50', 'spread': '12.31', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Week 16 (n=270)', 'categories': [{'measurements': [{'value': '45.17', 'spread': '12.32', 'groupId': 'OG000'}]}]}, {'title': 'MCS, Week 24 (n=264)', 'categories': [{'measurements': [{'value': '44.92', 'spread': '13.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': 'SF-36 Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Physical functioning, Screening (n=289)', 'categories': [{'measurements': [{'value': '39.04', 'spread': '24.83', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Week 8 (n=284)', 'categories': [{'measurements': [{'value': '43.60', 'spread': '24.50', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Week 16 (n=276)', 'categories': [{'measurements': [{'value': '44.64', 'spread': '25.13', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning, Week 24 (n=268)', 'categories': [{'measurements': [{'value': '47.37', 'spread': '26.19', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Screening (n=290)', 'categories': [{'measurements': [{'value': '25.94', 'spread': '17.75', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Week 8 (n=285)', 'categories': [{'measurements': [{'value': '37.24', 'spread': '19.00', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Week 16 (n=275)', 'categories': [{'measurements': [{'value': '44.25', 'spread': '21.60', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain, Week 24 (n=267)', 'categories': [{'measurements': [{'value': '44.06', 'spread': '22.13', 'groupId': 'OG000'}]}]}, {'title': 'Physical role functioning, Screening (n=290)', 'categories': [{'measurements': [{'value': '35.11', 'spread': '22.42', 'groupId': 'OG000'}]}]}, {'title': 'Physical role functioning, Week 8 (n=284)', 'categories': [{'measurements': [{'value': '43.72', 'spread': '23.95', 'groupId': 'OG000'}]}]}, {'title': 'Physical role functioning, Week 16 (n=276)', 'categories': [{'measurements': [{'value': '48.37', 'spread': '23.48', 'groupId': 'OG000'}]}]}, {'title': 'Physical role functioning, Week 24 (n=269)', 'categories': [{'measurements': [{'value': '49.63', 'spread': '25.04', 'groupId': 'OG000'}]}]}, {'title': 'Emotional role functioning, Screening (n=289)', 'categories': [{'measurements': [{'value': '52.77', 'spread': '31.23', 'groupId': 'OG000'}]}]}, {'title': 'Emotional role functioning, Week 8 (n=282)', 'categories': [{'measurements': [{'value': '59.13', 'spread': '27.26', 'groupId': 'OG000'}]}]}, {'title': 'Emotional role functioning, Week 16 (n=276)', 'categories': [{'measurements': [{'value': '62.41', 'spread': '27.57', 'groupId': 'OG000'}]}]}, {'title': 'Emotional role functioning, Week 24 (n=268)', 'categories': [{'measurements': [{'value': '61.29', 'spread': '27.98', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being, Screening (n=289)', 'categories': [{'measurements': [{'value': '56.11', 'spread': '20.07', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being, Week 8 (n=285)', 'categories': [{'measurements': [{'value': '60.43', 'spread': '19.82', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being, Week 16 (n=276)', 'categories': [{'measurements': [{'value': '63.02', 'spread': '20.51', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being, Week 24 (n=268)', 'categories': [{'measurements': [{'value': '64.03', 'spread': '21.03', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Screening (n=291)', 'categories': [{'measurements': [{'value': '56.62', 'spread': '27.23', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Week 8 (n=285)', 'categories': [{'measurements': [{'value': '64.04', 'spread': '25.87', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Week 16 (n=277)', 'categories': [{'measurements': [{'value': '65.93', 'spread': '26.10', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Week 24 (n=270)', 'categories': [{'measurements': [{'value': '66.99', 'spread': '28.11', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Screening (n=290)', 'categories': [{'measurements': [{'value': '38.49', 'spread': '19.41', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Week 8 (n=285)', 'categories': [{'measurements': [{'value': '43.42', 'spread': '19.76', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Week 16 (n=276)', 'categories': [{'measurements': [{'value': '48.25', 'spread': '20.32', 'groupId': 'OG000'}]}]}, {'title': 'Vitality, Week 24 (n=268)', 'categories': [{'measurements': [{'value': '48.22', 'spread': '20.75', 'groupId': 'OG000'}]}]}, {'title': 'General health perceptions, Screening (n=291)', 'categories': [{'measurements': [{'value': '39.14', 'spread': '14.49', 'groupId': 'OG000'}]}]}, {'title': 'General health perceptions, Week 8 (n=285)', 'categories': [{'measurements': [{'value': '45.61', 'spread': '15.06', 'groupId': 'OG000'}]}]}, {'title': 'General health perceptions, Week 16 (n=272)', 'categories': [{'measurements': [{'value': '48.54', 'spread': '17.16', 'groupId': 'OG000'}]}]}, {'title': 'General health perceptions, Week 24 (n=269)', 'categories': [{'measurements': [{'value': '48.30', 'spread': '17.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to two distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'ACR20, Week 8', 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}]}]}, {'title': 'ACR20, Week 16', 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}]}]}, {'title': 'ACR20, Week 24', 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}]}]}, {'title': 'ACR50, Week 8', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}]}]}, {'title': 'ACR50, Week 16', 'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000'}]}]}, {'title': 'ACR50, Week 24', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000'}]}]}, {'title': 'ACR70, Week 8', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'ACR70, Week 16', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'ACR70, Week 24', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 16, and 24', 'description': "ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in tender or swollen joint counts and ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participant assessment of functional disability via a HAQ-DI, and 5) C-reactive protein or ESR at each visit.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Swollen Joint Count (SJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=291)', 'categories': [{'measurements': [{'value': '10.01', 'spread': '5.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=288)', 'categories': [{'measurements': [{'value': '5.16', 'spread': '4.73', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=282)', 'categories': [{'measurements': [{'value': '4.22', 'spread': '4.07', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=272)', 'categories': [{'measurements': [{'value': '4.70', 'spread': '4.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.', 'unitOfMeasure': 'swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': 'Tender Joint Count (TJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=291)', 'categories': [{'measurements': [{'value': '12.62', 'spread': '6.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=288)', 'categories': [{'measurements': [{'value': '7.53', 'spread': '6.71', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=282)', 'categories': [{'measurements': [{'value': '6.04', 'spread': '6.31', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=272)', 'categories': [{'measurements': [{'value': '6.41', 'spread': '6.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.', 'unitOfMeasure': 'tender joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=291)', 'categories': [{'measurements': [{'value': '63.99', 'spread': '15.40', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=286)', 'categories': [{'measurements': [{'value': '39.20', 'spread': '19.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=280)', 'categories': [{'measurements': [{'value': '33.03', 'spread': '19.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=271)', 'categories': [{'measurements': [{'value': '35.75', 'spread': '23.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'Physicians assessed the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=291)', 'categories': [{'measurements': [{'value': '63.49', 'spread': '20.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=286)', 'categories': [{'measurements': [{'value': '46.19', 'spread': '23.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=278)', 'categories': [{'measurements': [{'value': '41.25', 'spread': '24.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=270)', 'categories': [{'measurements': [{'value': '41.47', 'spread': '25.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Pain", 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=291)', 'categories': [{'measurements': [{'value': '62.78', 'spread': '20.80', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=287)', 'categories': [{'measurements': [{'value': '47.30', 'spread': '23.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=276)', 'categories': [{'measurements': [{'value': '42.11', 'spread': '25.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=269)', 'categories': [{'measurements': [{'value': '41.76', 'spread': '25.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "unbearable pain".', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=289)', 'categories': [{'measurements': [{'value': '1.82', 'spread': '2.35', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 (n=233)', 'categories': [{'measurements': [{'value': '1.60', 'spread': '1.96', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (n=286)', 'categories': [{'measurements': [{'value': '1.81', 'spread': '2.27', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=283)', 'categories': [{'measurements': [{'value': '1.31', 'spread': '1.44', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=281)', 'categories': [{'measurements': [{'value': '1.21', 'spread': '1.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=269)', 'categories': [{'measurements': [{'value': '1.30', 'spread': '1.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Days 1 and 15, and Weeks 8, 16, and 24', 'description': 'Mean CRP as measured as an acute phase reactant by mg per deciliter (mg/dL) at screening, Days 1 and 15, and Weeks 8, 16, and 24.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=291)', 'categories': [{'measurements': [{'value': '30.20', 'spread': '20.56', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 (n=225)', 'categories': [{'measurements': [{'value': '28.07', 'spread': '19.51', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (n=277)', 'categories': [{'measurements': [{'value': '30.61', 'spread': '21.46', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=279)', 'categories': [{'measurements': [{'value': '24.85', 'spread': '16.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=276)', 'categories': [{'measurements': [{'value': '22.28', 'spread': '16.58', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=268)', 'categories': [{'measurements': [{'value': '23.64', 'spread': '17.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Days 1 and 15, and Weeks 8, 16, and 24', 'description': 'Mean ESR, as an acute phase reactant, measured in mm/hr at screening, Days 1 and 15, and Weeks 8, 16, and 24.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}, {'type': 'SECONDARY', 'title': 'Rheumatoid Factor (RF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'classes': [{'title': 'Screening (n=279)', 'categories': [{'measurements': [{'value': '178.23', 'spread': '352.61', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=255)', 'categories': [{'measurements': [{'value': '109.84', 'spread': '213.32', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=259)', 'categories': [{'measurements': [{'value': '88.22', 'spread': '174.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=258)', 'categories': [{'measurements': [{'value': '87.52', 'spread': '187.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'Mean RF as measured by international unit per milliliter (IU/mL) at screening and Weeks 8, 16, and 24.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed at a given visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rituximab Plus Methotrexate (MTX)', 'description': 'Participants received rituximab, 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '302'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '273'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Additional or changed therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Inclusion into ReFIRST', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rituximab + MTX', 'description': 'Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.4', 'spread': '18.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '228', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '301', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population: all participants who received at least 1 dose of trial medication and had at least 1 safety follow-up.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-30', 'studyFirstSubmitDate': '2014-03-04', 'resultsFirstSubmitDate': '2014-06-17', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-04', 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)', 'timeFrame': 'Week 24', 'description': "The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-ated rheumatoid arthritis \\[RA\\] activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\\>)3.2 to 5.1 = moderate to high disease activity."}], 'secondaryOutcomes': [{'measure': 'DAS28 Score', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': "The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant-rated RA assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity."}, {'measure': 'Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate', 'timeFrame': 'Weeks 8, 16, and 24', 'description': 'The DAS28-based EULAR response criteria were used to measure individual responses as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders experienced a change from baseline of \\>1.2 with a DAS28 score ≤3.2 and moderate responders experienced a change from baseline \\>1.2 with DAS28 \\>3.2 to ≤5.1 or a change from baseline \\>0.6 to ≤1.2 with a DAS28 score of ≤5.1.'}, {'measure': 'Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24', 'timeFrame': 'Week 24', 'description': "Percentage of participants with low disease activity defined as DAS28 ≤3.2 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity)."}, {'measure': 'Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24', 'timeFrame': 'Week 24', 'description': "Percentage of participants with remission defined as DAS28 \\<2.6 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity."}, {'measure': 'Percentage of Participants Achieving a Response By EULAR Category', 'timeFrame': 'Weeks 8, 16, and 24', 'description': "Percentage of participants achieving a response by EULAR category, including 'moderate', 'good', or no response at follow-up Weeks 8, 16, and 24. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline \\>1.2 with a DAS28 score ≤ 3.2; moderate responders had a change from baseline \\>1.2 with a DAS28 score of \\>3.2 to ≤5.1 or a change from baseline \\>0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline \\>0.6 and ≤1.2 with a DAS28 score of \\>5.1."}, {'measure': 'Health Assessment Questionnaire - Disability Index (HAQ-DI) Score', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).'}, {'measure': 'Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The FACIT fatigue scale is base on a 13-item questionnaire to assess the therapy-induced fatigue. Participants were requested to score each question on a scale ranging from 0 (best) to 4 (worst). The scoring system of the FACIT fatigue scale adds up to a total scale ranging from 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.'}, {'measure': 'Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS)', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.'}, {'measure': 'SF-36 Domain Scores', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to two distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70)', 'timeFrame': 'Weeks 8, 16, and 24', 'description': "ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in tender or swollen joint counts and ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participant assessment of functional disability via a HAQ-DI, and 5) C-reactive protein or ESR at each visit."}, {'measure': 'Swollen Joint Count (SJC)', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.'}, {'measure': 'Tender Joint Count (TJC)', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.'}, {'measure': "Physician's Global Assessment of Disease Activity", 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'Physicians assessed the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity).'}, {'measure': "Patient's Assessment of Disease Activity", 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity).'}, {'measure': "Patient's Assessment of Pain", 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "unbearable pain".'}, {'measure': 'C-Reactive Protein (CRP)', 'timeFrame': 'Screening, Days 1 and 15, and Weeks 8, 16, and 24', 'description': 'Mean CRP as measured as an acute phase reactant by mg per deciliter (mg/dL) at screening, Days 1 and 15, and Weeks 8, 16, and 24.'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'Screening, Days 1 and 15, and Weeks 8, 16, and 24', 'description': 'Mean ESR, as an acute phase reactant, measured in mm/hr at screening, Days 1 and 15, and Weeks 8, 16, and 24.'}, {'measure': 'Rheumatoid Factor (RF)', 'timeFrame': 'Screening and Weeks 8, 16, and 24', 'description': 'Mean RF as measured by international unit per milliliter (IU/mL) at screening and Weeks 8, 16, and 24.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-75 years of age;\n* rheumatoid arthritis for \\>=6 months;\n* previous inadequate response to a single anti-TNF alpha inhibitor;\n* methotrexate at a stable dose range 7.5-25 mg/week.\n\nExclusion Criteria:\n\n* other chronic inflammatory articular disease or systemic autoimmune disease;\n* previous treatment with MabThera or intolerance to MabThera;\n* corticosteroids\\>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at unstable doses within last 2 weeks;'}, 'identificationModule': {'nctId': 'NCT02079532', 'briefTitle': 'A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent', 'orgStudyIdInfo': {'id': 'ML19070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MabThera (Rituximab)', 'interventionNames': ['Drug: rituximab [MabThera]']}], 'interventions': [{'name': 'rituximab [MabThera]', 'type': 'DRUG', 'description': '1 g was given by intravenous infusion on Days 1 and 15', 'armGroupLabels': ['MabThera (Rituximab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93077', 'city': 'Bad Abbach', 'country': 'Germany', 'geoPoint': {'lat': 48.93754, 'lon': 12.04494}}, {'zip': '83043', 'city': 'Bad Aibling', 'country': 'Germany', 'geoPoint': {'lat': 47.8638, 'lon': 12.01055}}, {'zip': '24576', 'city': 'Bad Bramstedt', 'country': 'Germany', 'geoPoint': {'lat': 53.91827, 'lon': 9.88243}}, {'zip': '96047', 'city': 'Bamberg', 'country': 'Germany', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13055', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13589', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14163', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53111', 'city': 'Bonn', 'country': 'Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '28199', 'city': 'Bremen', 'country': 'Germany', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '27476', 'city': 'Cuxhaven', 'country': 'Germany', 'geoPoint': {'lat': 53.86828, 'lon': 8.69902}}, {'zip': '24351', 'city': 'Damp', 'country': 'Germany', 'geoPoint': {'lat': 54.58469, 'lon': 10.01785}}, {'zip': '78166', 'city': 'Donaueschingen', 'country': 'Germany', 'geoPoint': {'lat': 47.95514, 'lon': 8.49707}}, {'zip': '01109', 'city': 'Dresden', 'country': 'Germany', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40211', 'city': 'Düsseldorf', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '99096', 'city': 'Erfurt', 'country': 'Germany', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '91056', 'city': 'Erlangen', 'country': 'Germany', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45239', 'city': 'Essen', 'country': 'Germany', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45326', 'city': 'Essen', 'country': 'Germany', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '36039', 'city': 'Fulda', 'country': 'Germany', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '39245', 'city': 'Gommern', 'country': 'Germany', 'geoPoint': {'lat': 52.07391, 'lon': 11.82297}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '58135', 'city': 'Hagen', 'country': 'Germany', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '22081', 'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30159', 'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '44652', 'city': 'Herne', 'country': 'Germany', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '65719', 'city': 'Hofheim', 'country': 'Germany', 'geoPoint': {'lat': 49.65749, 'lon': 8.41385}}, {'zip': '66424', 'city': 'Homburg/saar', 'country': 'Germany'}, {'zip': '07743', 'city': 'Jena', 'country': 'Germany', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '76135', 'city': 'Karlsruhe', 'country': 'Germany', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '67063', 'city': 'Ludwigshafen', 'country': 'Germany', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '55122', 'city': 'Mainz', 'country': 'Germany', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '02763', 'city': 'Mittelherwigsdorf', 'country': 'Germany', 'geoPoint': {'lat': 50.91667, 'lon': 14.76667}}, {'zip': '41061', 'city': 'Mönchengladbach', 'country': 'Germany', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': '80335', 'city': 'München', 'country': 'Germany', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81541', 'city': 'München', 'country': 'Germany', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '04683', 'city': 'Naunhof', 'country': 'Germany', 'geoPoint': {'lat': 51.2777, 'lon': 12.58827}}, {'zip': '26121', 'city': 'Oldenburg', 'country': 'Germany', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': '49074', 'city': 'Osnabrück', 'country': 'Germany', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '01796', 'city': 'Pirna', 'country': 'Germany', 'geoPoint': {'lat': 50.95843, 'lon': 13.93702}}, {'zip': '40882', 'city': 'Ratingen', 'country': 'Germany', 'geoPoint': {'lat': 51.29724, 'lon': 6.84929}}, {'zip': '18059', 'city': 'Rostock', 'country': 'Germany', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '58239', 'city': 'Schwerte', 'country': 'Germany', 'geoPoint': {'lat': 51.44387, 'lon': 7.5675}}, {'zip': '48324', 'city': 'Sendenhorst', 'country': 'Germany', 'geoPoint': {'lat': 51.84303, 'lon': 7.82996}}, {'zip': '70178', 'city': 'Stuttgart', 'country': 'Germany', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '14929', 'city': 'Treuenbrietzen', 'country': 'Germany', 'geoPoint': {'lat': 52.09754, 'lon': 12.87258}}, {'zip': '54292', 'city': 'Trier', 'country': 'Germany', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '65189', 'city': 'Wiesbaden', 'country': 'Germany', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '65191', 'city': 'Wiesbaden', 'country': 'Germany', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '42105', 'city': 'Wuppertal', 'country': 'Germany', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'zip': '52146', 'city': 'Würselen', 'country': 'Germany', 'geoPoint': {'lat': 50.81809, 'lon': 6.1347}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '27404', 'city': 'Zeven', 'country': 'Germany', 'geoPoint': {'lat': 53.29657, 'lon': 9.27685}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}