Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-02 @ 12:55 AM
Study NCT ID:
NCT01010503
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2009-11-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tocilizumab With or Without Methotrexate in Patients With 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': 'C502936', 'term': 'tocilizumab'}]}}, '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 after the first publication or presentation that involves the overall study. 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': 'Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).', 'otherNumAtRisk': 32, 'otherNumAffected': 10, 'seriousNumAtRisk': 32, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Hepatopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Leucopenia+lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Acute bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Acute nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Acute pulpitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Crash of left foot local infection of skin and subcutaneous tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lumbago', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Adherent to Original Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'categories': [{'measurements': [{'value': '93.75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (ITT), all enrolled participants who received at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score Based on 28-Joint Count (DAS28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'title': 'Week 0 (n=32)', 'categories': [{'measurements': [{'value': '7.02', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=32)', 'categories': [{'measurements': [{'value': '4.30', 'spread': '1.04', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=30)', 'categories': [{'measurements': [{'value': '2.85', 'spread': '1.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=30)', 'categories': [{'measurements': [{'value': '2.57', 'spread': '0.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 12, and 24', 'description': "DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hr\\]) and 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 equals (=) low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Withdrawing From the Study Prematurely for Any Reason', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.25', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'categories': [{'measurements': [{'value': '18.75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, and 20', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'title': 'Week 0 (n=32)', 'categories': [{'measurements': [{'value': '59.91', 'spread': '14.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=32)', 'categories': [{'measurements': [{'value': '36.31', 'spread': '17.10', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=30)', 'categories': [{'measurements': [{'value': '22.3', 'spread': '15.79', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=30)', 'categories': [{'measurements': [{'value': '17.30', 'spread': '14.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=30)', 'categories': [{'measurements': [{'value': '18.93', 'spread': '14.59', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=30)', 'categories': [{'measurements': [{'value': '16.73', 'spread': '15.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=30)', 'categories': [{'measurements': [{'value': '14.87', 'spread': '11.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'title': 'Week 0 (n=32)', 'categories': [{'measurements': [{'value': '61.75', 'spread': '11.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=32)', 'categories': [{'measurements': [{'value': '35.59', 'spread': '16.62', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=30)', 'categories': [{'measurements': [{'value': '22.20', 'spread': '14.86', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=30)', 'categories': [{'measurements': [{'value': '18.20', 'spread': '14.57', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=30)', 'categories': [{'measurements': [{'value': '18.80', 'spread': '13.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=30)', 'categories': [{'measurements': [{'value': '18.13', 'spread': '18.49', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=30)', 'categories': [{'measurements': [{'value': '15.47', 'spread': '12.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': "The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'title': 'Week 0 (n=32)', 'categories': [{'measurements': [{'value': '59.63', 'spread': '7.89', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=32)', 'categories': [{'measurements': [{'value': '27.75', 'spread': '14.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=30)', 'categories': [{'measurements': [{'value': '17.40', 'spread': '9.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=30)', 'categories': [{'measurements': [{'value': '14.20', 'spread': '9.93', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=30)', 'categories': [{'measurements': [{'value': '13.00', 'spread': '8.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=30)', 'categories': [{'measurements': [{'value': '12.77', 'spread': '10.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=30)', 'categories': [{'measurements': [{'value': '12.47', 'spread': '8.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': "Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'Swollen Joint Count (SJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'title': 'Week 0 (n=32)', 'categories': [{'measurements': [{'value': '26.66', 'spread': '7.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=32)', 'categories': [{'measurements': [{'value': '12.03', 'spread': '8.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=30)', 'categories': [{'measurements': [{'value': '7.00', 'spread': '6.52', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=30)', 'categories': [{'measurements': [{'value': '5.33', 'spread': '6.47', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=30)', 'categories': [{'measurements': [{'value': '5.33', 'spread': '6.33', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=30)', 'categories': [{'measurements': [{'value': '4.20', 'spread': '5.088', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=30)', 'categories': [{'measurements': [{'value': '4.00', 'spread': '5.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.', 'unitOfMeasure': 'swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'Tender Joint Count (TJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'title': 'Week 0 (n=32)', 'categories': [{'measurements': [{'value': '16.16', 'spread': '5.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=32)', 'categories': [{'measurements': [{'value': '5.53', 'spread': '5.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=30)', 'categories': [{'measurements': [{'value': '1.97', 'spread': '2.01', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=30)', 'categories': [{'measurements': [{'value': '1.30', 'spread': '1.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=30)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=30)', 'categories': [{'measurements': [{'value': '0.83', 'spread': '1.315', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=30)', 'categories': [{'measurements': [{'value': '0.63', 'spread': '1.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.', 'unitOfMeasure': 'tender joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'title': 'Week 0 (n=32)', 'categories': [{'measurements': [{'value': '55.81', 'spread': '25.05', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=32)', 'categories': [{'measurements': [{'value': '16.69', 'spread': '10.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=30)', 'categories': [{'measurements': [{'value': '15.23', 'spread': '14.78', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=30)', 'categories': [{'measurements': [{'value': '14.17', 'spread': '17.81', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=30)', 'categories': [{'measurements': [{'value': '11.00', 'spread': '7.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 12, 20, and 24', 'description': 'ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TT population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'title': 'Week 0 (n=32)', 'categories': [{'measurements': [{'value': '17.84', 'spread': '21.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=32)', 'categories': [{'measurements': [{'value': '5.03', 'spread': '6.07', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=30)', 'categories': [{'measurements': [{'value': '5.54', 'spread': '9.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=30)', 'categories': [{'measurements': [{'value': '6.71', 'spread': '13.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=30)', 'categories': [{'measurements': [{'value': '2.97', 'spread': '0.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 12, 20, and 24', 'description': 'CRP is an acute phase protein. Levels of CRP increase with inflammation.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire - Disability Index (HAQ-DI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'title': 'Week 0 (n=32)', 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Week 4 (n=32)', 'categories': [{'measurements': [{'value': '1.56', 'spread': '0.49', 'groupId': 'OG000'}]}]}, {'title': 'Week 8 (n=30)', 'categories': [{'measurements': [{'value': '1.31', 'spread': '0.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=30)', 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (n=30)', 'categories': [{'measurements': [{'value': '1.23', 'spread': '0.64', 'groupId': 'OG000'}]}]}, {'title': 'Week 20 (n=30)', 'categories': [{'measurements': [{'value': '1.20', 'spread': '0.644', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n=30)', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': "The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}, {'type': 'SECONDARY', 'title': 'Short Form-36 (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'classes': [{'title': 'Physical Functioning, Week 0 (n=32)', 'categories': [{'measurements': [{'value': '26.08', 'spread': '18.09', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning, Week 12 (n=30)', 'categories': [{'measurements': [{'value': '44.50', 'spread': '27.58', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning, Week 24 (n=30)', 'categories': [{'measurements': [{'value': '47.22', 'spread': '31.92', 'groupId': 'OG000'}]}]}, {'title': 'Role limits due to physical health, Week 0 (n=32)', 'categories': [{'measurements': [{'value': '6.25', 'spread': '18.71', 'groupId': 'OG000'}]}]}, {'title': 'Role limits due to physical health, Week 12 (n=30)', 'categories': [{'measurements': [{'value': '49.17', 'spread': '45.34', 'groupId': 'OG000'}]}]}, {'title': 'Role limits due to physical health, Week 24 (n=30)', 'categories': [{'measurements': [{'value': '44.44', 'spread': '45.60', 'groupId': 'OG000'}]}]}, {'title': 'Role limits due to emotional prob., Week 0 (n=32)', 'categories': [{'measurements': [{'value': '16.67', 'spread': '34.23', 'groupId': 'OG000'}]}]}, {'title': 'Role limits due to emotional prob., Week 12 (n=30)', 'categories': [{'measurements': [{'value': '61.11', 'spread': '45.34', 'groupId': 'OG000'}]}]}, {'title': 'Role limits due to emotional prob., Week 24 (n=30)', 'categories': [{'measurements': [{'value': '55.56', 'spread': '48.47', 'groupId': 'OG000'}]}]}, {'title': 'Energy/fatigue, Week 0 (n=32)', 'categories': [{'measurements': [{'value': '30.31', 'spread': '17.93', 'groupId': 'OG000'}]}]}, {'title': 'Energy/ fatigue, Week 12 (n=30)', 'categories': [{'measurements': [{'value': '48.33', 'spread': '26.14', 'groupId': 'OG000'}]}]}, {'title': 'Energy/fatigue, Week 24 (n=30)', 'categories': [{'measurements': [{'value': '50.00', 'spread': '31.32', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being, Week 0 (n=32)', 'categories': [{'measurements': [{'value': '50.00', 'spread': '19.10', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being, Week 12 (n=30)', 'categories': [{'measurements': [{'value': '63.70', 'spread': '24.16', 'groupId': 'OG000'}]}]}, {'title': 'Emotional well-being, Week 24 (n=30)', 'categories': [{'measurements': [{'value': '65.33', 'spread': '32.92', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Week 0 (n=32)', 'categories': [{'measurements': [{'value': '39.45', 'spread': '17.61', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Week 12 (n=30)', 'categories': [{'measurements': [{'value': '60.83', 'spread': '25.36', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning, Week 24 (n=30)', 'categories': [{'measurements': [{'value': '62.50', 'spread': '35.11', 'groupId': 'OG000'}]}]}, {'title': 'Pain, Week 0 (n=32)', 'categories': [{'measurements': [{'value': '28.67', 'spread': '15.34', 'groupId': 'OG000'}]}]}, {'title': 'Pain, Week 12 (n=30)', 'categories': [{'measurements': [{'value': '55.75', 'spread': '27.63', 'groupId': 'OG000'}]}]}, {'title': 'Pain, Week 24 (n=30)', 'categories': [{'measurements': [{'value': '56.11', 'spread': '33.32', 'groupId': 'OG000'}]}]}, {'title': 'General health, Week 0 (n=32)', 'categories': [{'measurements': [{'value': '38.28', 'spread': '10.82', 'groupId': 'OG000'}]}]}, {'title': 'General health, Week 12 (n=30)', 'categories': [{'measurements': [{'value': '46.83', 'spread': '16.32', 'groupId': 'OG000'}]}]}, {'title': 'General health, Week 24 (n=30)', 'categories': [{'measurements': [{'value': '46.25', 'spread': '23.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 0, 12, and 24', 'description': 'The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; n=number of participants assessed for the specified parameter at a given visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tocilizumab 8 Milligrams Per Kilogram (mg/kg)', 'description': 'Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tocilizumab 8 mg/kg', 'description': 'Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.38', 'spread': '12.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Slovakia', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease Duration', 'classes': [{'categories': [{'measurements': [{'value': '11.97', 'spread': '10.55', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Phase/Stage', 'classes': [{'title': 'Phase/Stage I', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Phase/Stage II', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Phase/Stage III', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Phase/Stage IV', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Disease stages/phases of rheumatoid arthritis (RA): Stage I represents synovitis: synovial membrane becomes hyperemic and edematous; joint effusions with high cell count; x-rays will as yet show no destructive changes, but soft tissue swelling or osteoporosis may be seen; Stage II: inflamed synovial tissue now proliferates and begins to grow into joint cavity across articular cartilage, which it gradually destroys; Stage III: pannus of synovium; eroded articular cartilage and exposed subchondral bone x-rays will show extensive cartilage loss; Stage IV represents end-stage disease.', 'unitOfMeasure': 'participants'}, {'title': 'Functional Class of Disease', 'classes': [{'title': 'Class I', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Class IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Classification of global functional status in RA is as follows: Class I: completely able to perform usual activities of daily living (self-care, vocational, and avocational); Class II: able to perform usual self-care and vocational activities, but limited in avocational activities; Class III: able to perform usual self-care activities, but limited in vocational and avocational activities; and Class IV: limited in ability to perform usual self-care, vocational, and avocational activities.', 'unitOfMeasure': 'participants'}, {'title': 'C-Reactive Protein (CRP)', 'classes': [{'categories': [{'measurements': [{'value': '17.84', 'spread': '21.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'CRP was measured in milligrams per liter (mg/L)', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Erythrocyte Sedimentation Rate (ESR)', 'classes': [{'categories': [{'measurements': [{'value': '55.81', 'spread': '25.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'ESR was measured in millimeters per hour (mm/hr)', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-23', 'studyFirstSubmitDate': '2009-11-09', 'resultsFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2009-11-09', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-23', 'studyFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Adherent to Original Treatment', 'timeFrame': 'Week 24', 'description': 'Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.'}, {'measure': 'Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24'}, {'measure': 'Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24'}, {'measure': 'Percentage of Participants Withdrawing From the Study Prematurely for Any Reason', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24'}, {'measure': 'Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, and 20'}], 'secondaryOutcomes': [{'measure': 'Disease Activity Score Based on 28-Joint Count (DAS28)', 'timeFrame': 'Weeks 0, 4, 12, and 24', 'description': "DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hr\\]) and 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 equals (=) low disease activity, DAS28 \\>3.2 to 5.1 = moderate to high disease activity."}, {'measure': 'Patient Global Assessment of Pain', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.'}, {'measure': 'Patient Global Assessment of Disease Activity', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': "The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured."}, {'measure': "Physician's Global Assessment of Disease Activity", 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': "Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured."}, {'measure': 'Swollen Joint Count (SJC)', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.'}, {'measure': 'Tender Joint Count (TJC)', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': 'The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'Weeks 0, 4, 12, 20, and 24', 'description': 'ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.'}, {'measure': 'C-Reactive Protein (CRP)', 'timeFrame': 'Weeks 0, 4, 12, 20, and 24', 'description': 'CRP is an acute phase protein. Levels of CRP increase with inflammation.'}, {'measure': 'Health Assessment Questionnaire - Disability Index (HAQ-DI) Score', 'timeFrame': 'Weeks 0, 4, 8, 12, 16, 20, and 24', 'description': "The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability."}, {'measure': 'Short Form-36 (SF-36)', 'timeFrame': 'Weeks 0, 12, and 24', 'description': 'The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients \\>/= 18 years of age\n* moderate to severe active rheumatoid arthritis\n* inadequate response, or intolerance to previous therapy with one or more traditional DMARDs\n* DAS \\>3.6\n* pneumology examination (including chest x-ray and quantiferon)\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* active infection\n* active tuberculosis\n* uncontrolled hyperlipoproteinaemia\n* demyelinating disorders\n* concomitant anti-TNF drugs\n* history of intestinal ulceration and diverticulitis'}, 'identificationModule': {'nctId': 'NCT01010503', 'briefTitle': 'A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Evaluation of Adherence and Persistence to Tocilizumab in Combination With Methotrexate or Tocilizumab Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis in Local Environment.', 'orgStudyIdInfo': {'id': 'ML22508'}, 'secondaryIdInfos': [{'id': '2009-011520-53'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'interventionNames': ['Drug: tocilizumab [RoActemra/Actemra]']}], 'interventions': [{'name': 'tocilizumab [RoActemra/Actemra]', 'type': 'DRUG', 'description': 'tocilizumab 8 mg/kg intravenous infusion once in 4 weeks', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '921 12', 'city': 'Piešťany', 'country': 'Slovakia', 'geoPoint': {'lat': 48.59479, 'lon': 17.82591}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}