Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-10 @ 6:02 AM
Study NCT ID:
NCT01671059
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2012-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Non-Interventional Study Evaluating Rheumatoid Arthritis Participants Treated With Tocilizumab (RoActemra/Actemra)
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, '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': '6 months', 'description': 'An adverse event is any unfavorable or unintended sign or symptom associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'eventGroups': [{'id': 'EG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.', 'otherNumAtRisk': 80, 'otherNumAffected': 11, 'seriousNumAtRisk': 80, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gamma-Glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lack of drug effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Medication error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Dose Modifications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Reasons for Dose Modifications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Low level of neutrophils', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Adverse event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Other reason', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Unknown reason', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Dose Interruptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Adverse Event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Lack of Efficacy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants on Tocilizumab Monotherapy at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score Based on 28-Joint Count (DAS28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Combination therapy', 'categories': [{'measurements': [{'value': '2.78', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '5.25'}]}]}, {'title': 'Monotherapy', 'categories': [{'measurements': [{'value': '2.45', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '5.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour \\[mm/hour\\]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment \\[VAS\\]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Good response', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}]}]}, {'title': 'Moderate response', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}]}]}, {'title': 'No response', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. 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 response: change from baseline \\<-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline \\<-1.2 with DAS28 scores \\>3.2 to ≤ 5.1 or \\>5.1, or a change from baseline \\<-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and \\>3.2 to ≤5.1; No response: change from baseline \\<-0.6 to ≥-1.2 with DAS28 score \\>5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, \\>3.2 to ≤ 5.1, or \\>5.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Good response', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}]}]}, {'title': 'Moderate response', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'No response', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. 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 response: change from baseline \\<-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline \\<-1.2 with DAS28 scores \\>3.2 to ≤ 5.1 or \\>5.1, or a change from baseline \\<-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and \\>3.2 to ≤5.1; No response: change from baseline \\<-0.6 to ≥-1.2 with DAS28 score \\>5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, \\>3.2 to ≤ 5.1, or \\>5.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Simplified Disease Activity Index (SDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Combination therapy', 'categories': [{'measurements': [{'value': '6.69', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '27.20'}]}]}, {'title': 'Monotherapy', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '20.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Simplified Disease Activity Index (SDAI) is an index for measuring disease activity in RA and has a good correlation with the DAS28. The index is calculated using the following formula: SDAI: swollen joint count (SJC28) + tender joint count (TJC28) + physician global assessment (PGA) (10 cm visual analogue scale \\[VAS\\]) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in milligrams/liter (mg/L). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores range from 0 to 86, with higher scores also indicating increased disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Clinical Disease Activity Index (CDAI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Combination therapy', 'categories': [{'measurements': [{'value': '7.05', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '27.00'}]}]}, {'title': 'Monotherapy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '20.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter \\[cm\\] Visual Analog Scale \\[VAS\\] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores range from 0 to 76, with higher scores indicating increased disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology (ACR) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'ACR20 Response: Combination therapy', 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}]}]}, {'title': 'ACR20 Response: Monotherapy', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'ACR50 Response: Combination therapy', 'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000'}]}]}, {'title': 'ACR50 Response: Monotherapy', 'categories': [{'measurements': [{'value': '66.6', 'groupId': 'OG000'}]}]}, {'title': 'ACR70 Response: Combination therapy', 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000'}]}]}, {'title': 'ACR70 Response: Monotherapy', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': "ACR response was calculated based on total joint count evaluation and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (28 joints) and tender joint count (28 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, participant's global assessment of disease activity (PGH), physician's global assessment of disease activity (PhGH) (all 3 assessed at 0 \\[good\\] to 100 mm \\[worst\\] VAS scale); participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity); acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50 and ACR70 require a 50% and 70% improvement from baseline, respectively.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '13.75', 'groupId': 'OG000'}]}]}, {'title': 'AESI', 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'An AESI includes serious/medically significant infections; opportunistic infections; cases of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST), in combination with either elevated bilirubin or clinical jaundice; suspected transmission of an infectious agent by the study drug; myocardial infarction /acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis / hypersensitivity reactions (including injection site reactions); demyelinating disorders; stroke; serious/medically significant bleeding events; or serious/medically significant hepatic events.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants.'}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment of Disease Activity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Combination therapy', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '80'}]}]}, {'title': 'Monotherapy', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Combination therapy', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.13'}]}]}, {'title': 'Monotherapy', 'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': "The HAQ is a participant self-reported questionnaire for assessing the extent of the participant's functional ability. It consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale is an average of all the scores and ranges from 0 to 3, where higher scores represent higher disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale (VAS) for Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Combination therapy', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '70'}]}]}, {'title': 'Monotherapy', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue, and 100 indicates extreme fatigue. A decrease in the score indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale (VAS) for Morning Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Combination therapy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Monotherapy', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale (VAS) for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'classes': [{'title': 'Combination therapy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '80'}]}]}, {'title': 'Monotherapy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'The VAS-Pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.6', 'spread': '11.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Enrolled participants.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-06', 'studyFirstSubmitDate': '2012-08-20', 'resultsFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2012-08-22', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-07', 'studyFirstPostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Dose Modifications', 'timeFrame': '6 months'}, {'measure': 'Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)', 'timeFrame': '6 months'}, {'measure': 'Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents', 'timeFrame': 'Baseline'}, {'measure': 'Reasons for Dose Modifications', 'timeFrame': '6 months'}, {'measure': 'Percentage of Participants With Dose Interruptions', 'timeFrame': '6 months'}, {'measure': 'Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy', 'timeFrame': '6 months'}, {'measure': 'Percentage of Participants on Tocilizumab Monotherapy at Study Entry', 'timeFrame': '6 months'}, {'measure': 'Disease Activity Score Based on 28-Joint Count (DAS28)', 'timeFrame': '6 months', 'description': 'DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour \\[mm/hour\\]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment \\[VAS\\]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.'}, {'measure': 'Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category', 'timeFrame': '6 months', 'description': 'Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. 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 response: change from baseline \\<-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline \\<-1.2 with DAS28 scores \\>3.2 to ≤ 5.1 or \\>5.1, or a change from baseline \\<-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and \\>3.2 to ≤5.1; No response: change from baseline \\<-0.6 to ≥-1.2 with DAS28 score \\>5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, \\>3.2 to ≤ 5.1, or \\>5.1.'}, {'measure': 'Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category', 'timeFrame': '6 months', 'description': 'Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. 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 response: change from baseline \\<-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline \\<-1.2 with DAS28 scores \\>3.2 to ≤ 5.1 or \\>5.1, or a change from baseline \\<-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and \\>3.2 to ≤5.1; No response: change from baseline \\<-0.6 to ≥-1.2 with DAS28 score \\>5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, \\>3.2 to ≤ 5.1, or \\>5.1.'}, {'measure': 'Simplified Disease Activity Index (SDAI)', 'timeFrame': '6 months', 'description': 'Simplified Disease Activity Index (SDAI) is an index for measuring disease activity in RA and has a good correlation with the DAS28. The index is calculated using the following formula: SDAI: swollen joint count (SJC28) + tender joint count (TJC28) + physician global assessment (PGA) (10 cm visual analogue scale \\[VAS\\]) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in milligrams/liter (mg/L). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores range from 0 to 86, with higher scores also indicating increased disease activity.'}, {'measure': 'Clinical Disease Activity Index (CDAI) Score', 'timeFrame': '6 months', 'description': 'Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter \\[cm\\] Visual Analog Scale \\[VAS\\] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores range from 0 to 76, with higher scores indicating increased disease activity.'}, {'measure': 'Percentage of Participants With American College of Rheumatology (ACR) Response', 'timeFrame': '6 months', 'description': "ACR response was calculated based on total joint count evaluation and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (28 joints) and tender joint count (28 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, participant's global assessment of disease activity (PGH), physician's global assessment of disease activity (PhGH) (all 3 assessed at 0 \\[good\\] to 100 mm \\[worst\\] VAS scale); participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity); acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50 and ACR70 require a 50% and 70% improvement from baseline, respectively."}, {'measure': 'Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)', 'timeFrame': '6 months', 'description': 'An AESI includes serious/medically significant infections; opportunistic infections; cases of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST), in combination with either elevated bilirubin or clinical jaundice; suspected transmission of an infectious agent by the study drug; myocardial infarction /acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis / hypersensitivity reactions (including injection site reactions); demyelinating disorders; stroke; serious/medically significant bleeding events; or serious/medically significant hepatic events.'}, {'measure': 'Patient Global Assessment of Disease Activity Score', 'timeFrame': '6 months', 'description': 'The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.'}, {'measure': 'Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': '6 months', 'description': "The HAQ is a participant self-reported questionnaire for assessing the extent of the participant's functional ability. It consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale is an average of all the scores and ranges from 0 to 3, where higher scores represent higher disease activity."}, {'measure': 'Visual Analogue Scale (VAS) for Fatigue', 'timeFrame': '6 months', 'description': 'The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue, and 100 indicates extreme fatigue. A decrease in the score indicates improvement.'}, {'measure': 'Visual Analogue Scale (VAS) for Morning Stiffness', 'timeFrame': '6 months', 'description': 'Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.'}, {'measure': 'Visual Analogue Scale (VAS) for Pain', 'timeFrame': '6 months', 'description': 'The VAS-Pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This non-interventional study evaluated the use and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment according to the approved label were followed for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with rheumatoid arthritis initiated on treatment with tocilizumab (RoActemra/Actemra)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants, \\>/= 18 years of age\n* Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria\n* Participants in whom the treating physician made the decision to commence tocilizumab treatment (in accordance with the local label); this could include participants who had received tocilizumab treatment within 8 weeks prior to the enrollment visit\n\nExclusion Criteria:\n\n* Participants who had received tocilizumab more than 8 weeks prior to the enrollment visit\n* Participants who had previously received tocilizumab in a clinical trial or for compassionate use\n* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever was longer) before starting treatment with tocilizumab\n* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT01671059', 'briefTitle': 'A Non-Interventional Study Evaluating Rheumatoid Arthritis Participants Treated With Tocilizumab (RoActemra/Actemra)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multi-Center, Non-Interventional Study to Evaluate Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACROSS)', 'orgStudyIdInfo': {'id': 'ML28314'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Institut Za Reumatologiju; Reumatologiju', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Military Medical Academy; Clinic of Rheumatology', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '18205', 'city': 'Niška Banja', 'country': 'Serbia', 'facility': 'Institute of Rheumatology and Cardiovascular Diseases; Rheumatology', 'geoPoint': {'lat': 43.29507, 'lon': 22.0057}}, {'zip': '18205', 'city': 'Niška Banja', 'country': 'Serbia', 'geoPoint': {'lat': 43.29507, 'lon': 22.0057}}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia', 'facility': 'Clinical Center Voivodina; Clinic for Immunology and Nephrology', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia', 'facility': 'Special hospital for rheumatic diseases Novi Sad', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}