Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-03 @ 11:50 PM
Study NCT ID:
NCT01669902
Status:
COMPLETED
Last Update Posted:
2015-11-23
First Post:
2012-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Month 6', 'description': 'Safety Analysis Set', 'eventGroups': [{'id': 'EG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.', 'otherNumAtRisk': 107, 'otherNumAffected': 13, 'seriousNumAtRisk': 107, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood lactic acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants on Tocilizumab Treatment at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Dose Modifications of Tocilizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 6', 'description': 'Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Swollen Joint Count (SJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline (n=83)', 'categories': [{'measurements': [{'value': '5.6', 'spread': '5.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=73)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=63)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '2.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.', 'unitOfMeasure': 'swollen joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) (swollen joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for swollen joints. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Tender Joint Count (TJC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline (n=83)', 'categories': [{'measurements': [{'value': '8.6', 'spread': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=73)', 'categories': [{'measurements': [{'value': '4.5', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=63)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.', 'unitOfMeasure': 'tender joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS (tender joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for tender joints. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline (n=83)', 'categories': [{'measurements': [{'value': '4.76', 'spread': '1.31', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=69)', 'categories': [{'measurements': [{'value': '3.17', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=60)', 'categories': [{'measurements': [{'value': '2.98', 'spread': '1.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter \\[mg/L\\]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter \\[mm\\] Visual Analog Scale \\[VAS\\]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56\\*square root (sqrt) (TJC28) + 0.28\\*sqrt(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (\\<= 3.2) implied low disease activity and greater than (\\>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (\\<) 2.6 = clinical remission.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS (DAS28-4 \\[CRP\\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 \\[CRP\\] assessment. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Month 3 (n=69): Clinical remission', 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=60): Clinical remission', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 and Month 6', 'description': 'DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56\\*sqrt(TJC28) + 0.28\\*sqrt(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) \\<= 3.2 implied low disease activity and \\> 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) \\< 2.6 = clinical remission.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (DAS28-4 \\[CRP\\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline (n=59)', 'categories': [{'measurements': [{'value': '5.03', 'spread': '1.39', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=49)', 'categories': [{'measurements': [{'value': '2.98', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=45)', 'categories': [{'measurements': [{'value': '2.64', 'spread': '1.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour \\[mm/hour\\]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56\\*sqrt(TJC28) + 0.28\\*sqrt(SJC28) + 0.70\\*ln(ESR) + 0.014\\*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) \\<= 3.2 implied low disease activity and \\>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \\<2.6 = clinical remission.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS (DAS28-4 \\[ESR\\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 \\[ESR\\] assessment. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Month 3 (n=49): Clinical remission', 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=45) : Clinical remission', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 and Month 6', 'description': 'DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56\\*sqrt(TJC28) + 0.28\\*sqrt(SJC28) + 0.70\\*ln(ESR) + 0.014\\*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) \\<= 3.2 implied low disease activity and \\>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \\<2.6 = clinical remission.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (DAS28-4 \\[ESR\\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Month 3: Good response (n=69)', 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: Moderate response (n=69)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: No response (n=69)', 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Good response (n=60)', 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Moderate response (n=60)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: No response (n=60)', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 and Month 6', 'description': 'The DAS28-4 (CRP) \\[described in Outcome Measure 5\\] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline \\>1.2 with DAS28 \\<= 3.2; moderate responders: change from baseline \\>1.2 with DAS28 in the range of \\>3.2 to \\<=5.1 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 in the range of \\>3.2 to \\<=5.1 or change from baseline \\>1.2 with DAS28 \\>5.1 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 \\<=3.2; non-responders: change from baseline \\<= 0.6 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 \\>5.1 or change from baseline \\<=0.6 with DAS28 \\<=3.2 or in the range of \\>3.2 to \\<=5.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (DAS28-4 \\[CRP\\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Month 3: Good response (n=49)', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: Moderate response (n=49)', 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: No response (n=49)', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Good response (n=45)', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Moderate response (n=45)', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: No response (n=45)', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 and Month 6', 'description': 'The DAS28-4 (ESR) \\[described in Outcome Measure 7\\] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline \\>1.2 with DAS28 \\<= 3.2; moderate responders: change from baseline \\>1.2 with DAS28 in the range of \\>3.2 to \\<=5.1 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 in the range of \\>3.2 to \\<=5.1 or change from baseline \\>1.2 with DAS28 \\>5.1 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 \\<=3.2; non-responders: change from baseline \\<= 0.6 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 \\>5.1 or change from baseline \\<=0.6 with DAS28 \\<=3.2 or in the range of \\>3.2 to \\<=5.1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (DAS28-4 \\[ESR\\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Simplified Disease Activity Index (SDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline (n=34)', 'categories': [{'measurements': [{'value': '22.46', 'spread': '11.33', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=31)', 'categories': [{'measurements': [{'value': '11.48', 'spread': '9.18', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=24)', 'categories': [{'measurements': [{'value': '10.73', 'spread': '11.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI \\<=3.3 indicates clinical remission, \\>3.4 to 11 = low disease activity, \\>11 to 26 = moderate disease activity, and \\>26 = high (or severe) disease activity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS (SDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for SDAI. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission Based on SDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Month 3 (n=31): Clinical remission', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=24): Clinical remission', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 and Month 6', 'description': 'The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI \\<=3.3 indicates clinical remission, \\>3.4 to 11 = low disease activity, \\>11 to 26 = moderate disease activity, and \\>26 = high (or severe) disease activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (SDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Clinical Disease Activity Index (CDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline (n=35)', 'categories': [{'measurements': [{'value': '21.3', 'spread': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=33)', 'categories': [{'measurements': [{'value': '10.9', 'spread': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=24)', 'categories': [{'measurements': [{'value': '10.4', 'spread': '11.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI \\<= 2.8 indicates clinical remission, \\>2.8 to 10 = low disease activity, \\>10 to 22 = moderate disease activity, and \\>22 = high (or severe) disease activity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS (CDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for CDAI. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission Based on CDAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Month 3 (n=33): Clinical remission', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=24): Clinical remission', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 and Month 6', 'description': 'The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI \\<= 2.8 indicates clinical remission, \\>2.8 to 10 = low disease activity, \\>10 to 22 = moderate disease activity, and \\>22 = high (or severe) disease activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (CDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an American College of Rheumatology (ACR) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'timeFrame': 'Baseline to Month 6', 'description': "ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data for ACR response was not reported because in clinical practice the 66/68 joint evaluation needed for this is not performed in the Sweden, Denmark and Norway, the 28 joint count is performed instead.'}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment (PtGA) of Disease Activity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline (n=87)', 'categories': [{'measurements': [{'value': '61.6', 'spread': '21.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=77)', 'categories': [{'measurements': [{'value': '41.3', 'spread': '25.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=69)', 'categories': [{'measurements': [{'value': '41.6', 'spread': '26.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS (VAS disease activity \\[patient\\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (patient). n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Physician Global Assessment (PGA) of Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline (n=42)', 'categories': [{'measurements': [{'value': '34.0', 'spread': '16.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=37)', 'categories': [{'measurements': [{'value': '19.1', 'spread': '17.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=30)', 'categories': [{'measurements': [{'value': '15.2', 'spread': '14.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS (VAS disease activity \\[physician\\] included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (physician). n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in a PGA of Disease Activity Score Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline: Mild (n=51)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Moderate (n=51)', 'categories': [{'measurements': [{'value': '56.9', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Severe (n=51)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Maximal (n=51)', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: None (n=46)', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: Mild (n=46)', 'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: Moderate (n=46)', 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: Severe (n=46)', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: None (n=41)', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Mild (n=46)', 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Moderate (n=46)', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Severe (n=46)', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (categorical scale \\[physician\\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for rheumatoid arthritis illness categorical scale (physician). n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline (n=83)', 'categories': [{'measurements': [{'value': '60.5', 'spread': '22.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 (n=73)', 'categories': [{'measurements': [{'value': '38.4', 'spread': '24.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 (n=68)', 'categories': [{'measurements': [{'value': '39.9', 'spread': '27.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS (VAS pain) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS pain. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Morning Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline: Yes (n=89)', 'categories': [{'measurements': [{'value': '55.1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: No (n=89)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Do Not Know (n=89)', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: Yes (n=80)', 'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: No (n=80)', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: Do Not Know (n=80)', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Yes (n=68)', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: No (n=68)', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: Do Not Know (n=68)', 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'The percentage of participants with morning stiffness ("yes", "no", or "do not know") was assessed at each visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (morning stiffness) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or 6) for morning stiffness. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Duration of Morning Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline: <30 minutes (n=49)', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: 30 to 60 minutes (n=49)', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: 60 to 120 minutes (n=49)', 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: 120 to 240 minutes (n=49)', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: >240 minutes (n=49)', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: whole day (n=49)', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: <30 minutes (n=38)', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: 30 to 60 minutes (n=38)', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: 60 to 120 minutes (n=38)', 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: 120 to 240 minutes (n=38)', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: >240 minutes (n=38)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 3: whole day (n=38)', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: <30 minutes (n=25)', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: 30 to 60 minutes (n=25)', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: 60 to 120 minutes (n=25)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: 120 to 240 minutes (n=25)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: >240 minutes (n=25)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6: whole day (n=25)', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (\\<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (\\>) 240 minutes, or whole day.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (morning stiffness). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'title': 'Baseline (n=82)', 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 (n=72)', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 (n=58)', 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.59', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change at Month 3', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0357', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Change at Month 6', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3 and Month 6', 'description': 'HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS (HAQ) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for HAQ.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Concomitant Corticosteroids Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 6', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 6', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tocilizumab', 'description': 'Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '13.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set included all data from all participants who received at least one injection with tocilizumab.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2012-08-13', 'resultsFirstSubmitDate': '2015-10-21', 'studyFirstSubmitQcDate': '2012-08-17', 'lastUpdatePostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-21', 'studyFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants on Tocilizumab Treatment at Month 6', 'timeFrame': 'Month 6'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Dose Modifications of Tocilizumab', 'timeFrame': 'Baseline to Month 6', 'description': 'Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.'}, {'measure': 'Swollen Joint Count (SJC)', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.'}, {'measure': 'Tender Joint Count (TJC)', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.'}, {'measure': 'Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter \\[mg/L\\]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter \\[mm\\] Visual Analog Scale \\[VAS\\]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56\\*square root (sqrt) (TJC28) + 0.28\\*sqrt(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (\\<= 3.2) implied low disease activity and greater than (\\>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (\\<) 2.6 = clinical remission.'}, {'measure': 'Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)', 'timeFrame': 'Month 3 and Month 6', 'description': 'DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56\\*sqrt(TJC28) + 0.28\\*sqrt(SJC28) + 0.36\\*ln(CRP+1) + 0.014\\*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) \\<= 3.2 implied low disease activity and \\> 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) \\< 2.6 = clinical remission.'}, {'measure': 'Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour \\[mm/hour\\]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56\\*sqrt(TJC28) + 0.28\\*sqrt(SJC28) + 0.70\\*ln(ESR) + 0.014\\*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) \\<= 3.2 implied low disease activity and \\>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \\<2.6 = clinical remission.'}, {'measure': 'Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)', 'timeFrame': 'Month 3 and Month 6', 'description': 'DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56\\*sqrt(TJC28) + 0.28\\*sqrt(SJC28) + 0.70\\*ln(ESR) + 0.014\\*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) \\<= 3.2 implied low disease activity and \\>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \\<2.6 = clinical remission.'}, {'measure': 'Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)', 'timeFrame': 'Month 3 and Month 6', 'description': 'The DAS28-4 (CRP) \\[described in Outcome Measure 5\\] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline \\>1.2 with DAS28 \\<= 3.2; moderate responders: change from baseline \\>1.2 with DAS28 in the range of \\>3.2 to \\<=5.1 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 in the range of \\>3.2 to \\<=5.1 or change from baseline \\>1.2 with DAS28 \\>5.1 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 \\<=3.2; non-responders: change from baseline \\<= 0.6 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 \\>5.1 or change from baseline \\<=0.6 with DAS28 \\<=3.2 or in the range of \\>3.2 to \\<=5.1.'}, {'measure': 'Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)', 'timeFrame': 'Month 3 and Month 6', 'description': 'The DAS28-4 (ESR) \\[described in Outcome Measure 7\\] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline \\>1.2 with DAS28 \\<= 3.2; moderate responders: change from baseline \\>1.2 with DAS28 in the range of \\>3.2 to \\<=5.1 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 in the range of \\>3.2 to \\<=5.1 or change from baseline \\>1.2 with DAS28 \\>5.1 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 \\<=3.2; non-responders: change from baseline \\<= 0.6 or change from baseline in the range of \\>0.6 to \\<=1.2 with DAS28 \\>5.1 or change from baseline \\<=0.6 with DAS28 \\<=3.2 or in the range of \\>3.2 to \\<=5.1.'}, {'measure': 'Simplified Disease Activity Index (SDAI)', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI \\<=3.3 indicates clinical remission, \\>3.4 to 11 = low disease activity, \\>11 to 26 = moderate disease activity, and \\>26 = high (or severe) disease activity.'}, {'measure': 'Percentage of Participants Achieving Clinical Remission Based on SDAI', 'timeFrame': 'Month 3 and Month 6', 'description': 'The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI \\<=3.3 indicates clinical remission, \\>3.4 to 11 = low disease activity, \\>11 to 26 = moderate disease activity, and \\>26 = high (or severe) disease activity.'}, {'measure': 'Clinical Disease Activity Index (CDAI)', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI \\<= 2.8 indicates clinical remission, \\>2.8 to 10 = low disease activity, \\>10 to 22 = moderate disease activity, and \\>22 = high (or severe) disease activity.'}, {'measure': 'Percentage of Participants Achieving Clinical Remission Based on CDAI', 'timeFrame': 'Month 3 and Month 6', 'description': 'The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI \\<= 2.8 indicates clinical remission, \\>2.8 to 10 = low disease activity, \\>10 to 22 = moderate disease activity, and \\>22 = high (or severe) disease activity.'}, {'measure': 'Number of Participants With an American College of Rheumatology (ACR) Response', 'timeFrame': 'Baseline to Month 6', 'description': "ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count."}, {'measure': 'Patient Global Assessment (PtGA) of Disease Activity Score', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.'}, {'measure': 'Physician Global Assessment (PGA) of Disease Activity', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.'}, {'measure': 'Percentage of Participants in a PGA of Disease Activity Score Category', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.'}, {'measure': 'Patient Global Assessment of Pain', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.'}, {'measure': 'Percentage of Participants With Morning Stiffness', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'The percentage of participants with morning stiffness ("yes", "no", or "do not know") was assessed at each visit.'}, {'measure': 'Percentage of Participants With Duration of Morning Stiffness', 'timeFrame': 'Baseline, Month 3, Month 6', 'description': 'Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (\\<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (\\>) 240 minutes, or whole day.'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6', 'timeFrame': 'Baseline, Month 3 and Month 6', 'description': 'HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.'}, {'measure': 'Percentage of Participants With Concomitant Corticosteroids Treatment', 'timeFrame': 'Baseline to Month 6'}, {'measure': 'Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study', 'timeFrame': 'Baseline to Month 6'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with active moderate to severe rheumatoid arthritis unable to use methotrexate', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria\n* Patients who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment visit may be included\n* Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or corticosteroids (orally or intra-articularly) is allowed\n\nExclusion Criteria:\n\n* Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment visit\n* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use\n* Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)\n* Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting RoActemra/Actemra treatment\n* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT01669902', 'briefTitle': 'An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'HAQIMONO a Non-interventional National Multicenter Study, Observing RA Patients Treated With Tocilizumab in Mono-therapy, i.e. Without Combination With DMARD', 'orgStudyIdInfo': {'id': 'ML28247'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '4300', 'city': 'Holbæk', 'country': 'Denmark', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}, {'zip': '6000', 'city': 'Kolding', 'country': 'Denmark', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}, {'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'zip': '5700', 'city': 'Svendborg', 'country': 'Denmark', 'geoPoint': {'lat': 55.05982, 'lon': 10.60677}}, {'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': '5053', 'city': 'Bergen', 'country': 'Norway', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '1346', 'city': 'Gjettum', 'country': 'Norway', 'geoPoint': {'lat': 59.90607, 'lon': 10.52911}}, {'zip': 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