Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-29 @ 7:53 PM
Study NCT ID:
NCT05576051
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2022-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Estimate the Efficacy of Treatment With TNFi as Monotherapy or Combination Therapy With MTX and Compare and Contrast Efficacy With Tofacitinib as Monotherapy and Combination Therapy in a Real World Setting.
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': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Not applicable as adverse events and all-cause mortality were not planned to be evaluated for the study.', 'description': 'Due to non-interventional nature of the study and nature of data sources, the minimum criteria for reporting an adverse event (that is, identifiable participant, identifiable reporter, a suspect product, and event) could not be met, hence adverse events were not planned to be evaluated (thus at risk appears "0").', 'eventGroups': [{'id': 'EG000', 'title': 'All TNFi Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'All TNFi Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TNFi Initiators After 11/6/2012 Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'TNFi Initiators After 11/6/2012 Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.1', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '17', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Non-switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed (n)" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'OG000'}, {'value': '1716', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFi Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'All TNFI Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'OG000'}, {'value': '1716', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '13.8', 'groupId': 'OG001'}]}]}, {'title': 'Non-switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3601', 'groupId': 'OG000'}, {'value': '1414', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "n" signifies number of participants evaluable for specified rows. Due to change in planned analysis, data for TNFi initiators after 11/6/2012 combination and monotherapy arms were not evaluable for CDAI score outcome measure as CDAI score data were not available in medical records for any participant in TNFi initiators after 11/6/2012 combination and monotherapy arms.'}, {'type': 'SECONDARY', 'title': 'CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFi Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '17', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Non-switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3601', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1716', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFI Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1716', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Non-switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1414', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.9', 'spread': '13', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '14.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFi Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Non-switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3601', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '14.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1716', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFI Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'title': 'All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1716', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '17', 'spread': '13.4', 'groupId': 'OG001'}]}]}, {'title': 'Non-switchers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1414', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.9', 'spread': '13', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall number of Participants Analyzed (N)" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4013', 'groupId': 'OG000'}, {'value': '1683', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFi Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'All TNFI Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'measurements': [{'value': '1224', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "N" signifies number of participants evaluable for this outcome measure. Due to change in planned analysis, data for TNFi initiators after 11/6/2012 combination and monotherapy arms were not evaluable for mACR20 outcome measure as mACR20 data were not available in medical records for any participant in TNFi initiators after 11/6/2012 combination and monotherapy arms.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4013', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFi Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'measurements': [{'value': '1224', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1683', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFI Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'measurements': [{'value': '394', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4013', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFi Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'measurements': [{'value': '1224', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1683', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFI Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'measurements': [{'value': '394', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Line of Therapy at TNFi Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5077', 'groupId': 'OG000'}, {'value': '2275', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFi Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'All TNFI Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'title': '1st line', 'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}, {'title': '2nd line', 'measurements': [{'value': '2109', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}]}, {'title': '3rd line', 'measurements': [{'value': '1088', 'groupId': 'OG000'}, {'value': '581', 'groupId': 'OG001'}]}, {'title': '4th line', 'measurements': [{'value': '656', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '1021', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of 1st line, 2nd line, 3rd line, and 4th line of therapy was reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '987', 'groupId': 'OG000'}, {'value': '745', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TNFi Initiators After 11/6/2012 Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'TNFI Initiators After 11/6/2012 Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'title': '1st line', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}, {'title': '2nd line', 'measurements': [{'value': '388', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}, {'title': '3rd line', 'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}, {'title': '4th line', 'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at TNFi initiation after 11/6/2012 was reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Line of Therapy at Tofacitinib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'title': '1st line', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': '2nd line', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': '3rd line', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': '4th line', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}, {'title': 'Missing', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at tofacitinib initiation was reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Median CDAI Score at Baseline- TNFi Initiator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'OG000'}, {'value': '1716', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFi Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'All TNFI Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '29.3'}, {'value': '19.7', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '29.9'}]}]}], 'analyses': [{'pValue': '0.278', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed model linear regression', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed model linear regression with propensity-score matched pairs as the random effect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi Initiator.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Median CDAI Score at Baseline- Tofacitinib Initiator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '33.1'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '28.3'}]}]}], 'analyses': [{'pValue': '0.131', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed model linear regression', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed model linear regression with propensity-score matched pairs as the random effect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of Tofacitinib Initiator.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '838', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TNFi Initiators After 11/6/2012 Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'TNFI Initiators After 11/6/2012 Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '11.5', 'upperLimit': '30.5'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '30'}]}]}], 'analyses': [{'pValue': '0.987', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed model linear regression', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed model linear regression with propensity-score matched pairs as the random effect.'}], 'paramType': 'MEDIAN', 'timeFrame': 'At baseline', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi initiator after 11-6-2012.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2341', 'groupId': 'OG000'}, {'value': '1396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All TNFi Initiators Combination(Restricted to 3+Line of Therapy: Prior Use of at Least One Biologic)', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'All TNFI Initiators Monotherapy(Restricted to 3+Line of Therapy: Prior Use of at Least One Biologic)', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'title': 'Adalimumab', 'categories': [{'measurements': [{'value': '975', 'groupId': 'OG000'}, {'value': '634', 'groupId': 'OG001'}]}]}, {'title': 'Etanercept', 'categories': [{'measurements': [{'value': '1286', 'groupId': 'OG000'}, {'value': '872', 'groupId': 'OG001'}]}]}, {'title': 'Infliximab', 'categories': [{'measurements': [{'value': '707', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}]}]}, {'title': 'Golimumab', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Certolizumab pegol', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}, {'title': 'Abatacept', 'categories': [{'measurements': [{'value': '295', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Tocilizumab', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Anakinra', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at TNFi initiation was reported in this outcome measure. Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012', 'denoms': [{'units': 'Participants', 'counts': [{'value': '517', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TNFi Initiators After 11/6/2012 Combination(Restricted to 3+LOT:Prior Use of at Least One Biologic)', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'TNFI Initiators After 11/6/2012 Monotherapy(Restricted to 3+LOT: Prior Use of at Least One Biologic)', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'title': 'Adalimumab', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}]}, {'title': 'Etanercept', 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}]}, {'title': 'Infliximab', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Golimumab', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Certolizumab pegol', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Abatacept', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Tocilizumab', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Anakinra', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy (LOT): prior use of at least one biologic) use at TNFi initiation after 11/6/2012 was reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib Initiators Combination(Restricted to 3+Lineoftherapy:Prior Use of at Least One Biologic)', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'OG001', 'title': 'Tofacitinib Initiators Monotherapy(Restricted to 3+Lineoftherapy:Prior Use of at Least One Biologic)', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'classes': [{'title': 'Adalimumab', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': 'Etanercept', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Infliximab', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Golimumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Certolizumab pegol', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Abatacept', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'Rituximab', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Tocilizumab', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Anakinra', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline', 'description': 'Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at tofacitinib initiation was reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Tumor Necrosis Factor Inhibitor (TNFi) Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'FG001', 'title': 'All TNFi Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'FG002', 'title': 'TNFi Initiators After 11/6/2012 Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'FG003', 'title': 'TNFi Initiators After 11/6/2012 Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'FG004', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'FG005', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5077'}, {'groupId': 'FG001', 'numSubjects': '2275'}, {'groupId': 'FG002', 'numSubjects': '987'}, {'groupId': 'FG003', 'numSubjects': '494'}, {'groupId': 'FG004', 'numSubjects': '124'}, {'groupId': 'FG005', 'numSubjects': '202'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4215'}, {'groupId': 'FG001', 'numSubjects': '1724'}, {'groupId': 'FG002', 'numSubjects': '825'}, {'groupId': 'FG003', 'numSubjects': '394'}, {'groupId': 'FG004', 'numSubjects': '86'}, {'groupId': 'FG005', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '862'}, {'groupId': 'FG001', 'numSubjects': '551'}, {'groupId': 'FG002', 'numSubjects': '162'}, {'groupId': 'FG003', 'numSubjects': '100'}, {'groupId': 'FG004', 'numSubjects': '38'}, {'groupId': 'FG005', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '543'}, {'groupId': 'FG001', 'numSubjects': '343'}, {'groupId': 'FG002', 'numSubjects': '108'}, {'groupId': 'FG003', 'numSubjects': '72'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '50'}]}, {'type': 'Safety', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Efficacy + Safety', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Data from greater than (\\>) 5500 participants who initiated Tumor Necrosis Factor Inhibitor (TNFi) initiation as combination with Methotrexate (MTX) and \\>2000 participants who initiated TNFi initiations as monotherapy; \\> 500 participants who initiated Tofacitinib initiations as monotherapy or as combination with MTX were observed in this non-interventional observational study.', 'preAssignmentDetails': 'Participants diagnosed with rheumatoid arthritis (RA), enrolled in Corrona US-based observational RA registry were included in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'All TNFi Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'BG001', 'title': 'All TNFi Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'BG002', 'title': 'TNFi Initiators After 11/6/2012 Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators treatment with combination of MTX on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'BG003', 'title': 'TNFi Initiators After 11/6/2012 Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated TNFi initiators monotherapy treatment on or after 6 November 2012 were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'BG004', 'title': 'Tofacitinib Initiators Combination', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators treatment with combination of MTX were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'BG005', 'title': 'Tofacitinib Initiators Monotherapy', 'description': 'Participants diagnosed with RA, enrolled in Corrona RA registry who initiated Tofacitinib initiators monotherapy treatment were included in this reporting group. Data was collected for this study from 4-Jun-2015.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'All TNFi initiators combination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4056', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '65'}, {'value': '56', 'groupId': 'BG006', 'lowerLimit': '48', 'upperLimit': '65'}]}]}, {'title': 'All TNFi initiators monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1716', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '63'}, {'value': '55', 'groupId': 'BG006', 'lowerLimit': '46', 'upperLimit': '63'}]}]}, {'title': 'TNFi initiators after 11/6/2012 combination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '838', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '66'}, {'value': '58', 'groupId': 'BG006', 'lowerLimit': '50', 'upperLimit': '66'}]}]}, {'title': 'TNFi initiators after 11/6/2012 monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '406', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG003', 'lowerLimit': '46', 'upperLimit': '64'}, {'value': '55', 'groupId': 'BG006', 'lowerLimit': '46', 'upperLimit': '64'}]}]}, {'title': 'Tofacitinib initiators combination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '96', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG004', 'lowerLimit': '53', 'upperLimit': '67'}, {'value': '59', 'groupId': 'BG006', 'lowerLimit': '53', 'upperLimit': '67'}]}]}, {'title': 'Tofacitinib initiators monotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '145', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG005', 'lowerLimit': '52', 'upperLimit': '66'}, {'value': '59', 'groupId': 'BG006', 'lowerLimit': '52', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Here, "Number Analyzed" signifies number of participants evaluable for specified arms.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3121', 'groupId': 'BG000'}, {'value': '1354', 'groupId': 'BG001'}, {'value': '653', 'groupId': 'BG002'}, {'value': '330', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}, {'value': '118', 'groupId': 'BG005'}, {'value': '5652', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '935', 'groupId': 'BG000'}, {'value': '362', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '1605', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '485', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3800', 'groupId': 'BG000'}, {'value': '1606', 'groupId': 'BG001'}, {'value': '767', 'groupId': 'BG002'}, {'value': '378', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}, {'value': '131', 'groupId': 'BG005'}, {'value': '6772', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '87', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '461', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '3389', 'groupId': 'BG000'}, {'value': '1454', 'groupId': 'BG001'}, {'value': '675', 'groupId': 'BG002'}, {'value': '335', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}, {'value': '118', 'groupId': 'BG005'}, {'value': '6055', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '349', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '654', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Cardiovascular disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '306', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '570', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of cancer excluding nonmelanoma skin cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '341', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '588', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoker', 'classes': [{'title': 'Never smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '2084', 'groupId': 'BG000'}, {'value': '864', 'groupId': 'BG001'}, {'value': '388', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '78', 'groupId': 'BG005'}, {'value': '3658', 'groupId': 'BG006'}]}]}, {'title': 'Previous smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '1163', 'groupId': 'BG000'}, {'value': '514', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '45', 'groupId': 'BG005'}, {'value': '2149', 'groupId': 'BG006'}]}]}, {'title': 'Current smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '787', 'groupId': 'BG000'}, {'value': '327', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '1397', 'groupId': 'BG006'}]}]}, {'title': 'Unknown or not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Work Status', 'classes': [{'title': 'Full Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '1697', 'groupId': 'BG000'}, {'value': '672', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '2920', 'groupId': 'BG006'}]}]}, {'title': 'Part time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '412', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '722', 'groupId': 'BG006'}]}]}, {'title': 'Work at home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '424', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '740', 'groupId': 'BG006'}]}]}, {'title': 'Student', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '177', 'groupId': 'BG006'}]}]}, {'title': 'Retired', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '526', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '1055', 'groupId': 'BG006'}]}]}, {'title': 'Disabled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '884', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '1563', 'groupId': 'BG006'}]}]}, {'title': 'Unknown or not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance', 'classes': [{'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '186', 'groupId': 'BG006'}]}]}, {'title': 'Private', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '3059', 'groupId': 'BG000'}, {'value': '1293', 'groupId': 'BG001'}, {'value': '609', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '112', 'groupId': 'BG005'}, {'value': '5431', 'groupId': 'BG006'}]}]}, {'title': 'Medicaid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '242', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '442', 'groupId': 'BG006'}]}]}, {'title': 'Medicare', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4056', 'groupId': 'BG000'}, {'value': '1716', 'groupId': 'BG001'}, {'value': '838', 'groupId': 'BG002'}, {'value': '406', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '145', 'groupId': 'BG005'}, {'value': '7257', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '1054', 'groupId': 'BG000'}, {'value': '454', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}, {'value': '1946', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included all eligible participants whose data were observed in this study.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9159}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2015-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2022-10-07', 'resultsFirstSubmitDate': '2025-10-30', 'studyFirstSubmitQcDate': '2022-10-07', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-04', 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX)', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported."}], 'secondaryOutcomes': [{'measure': 'CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported."}, {'measure': 'CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported."}, {'measure': 'CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported."}, {'measure': 'CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported."}, {'measure': 'CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy', 'timeFrame': 'At month 6 follow up visit', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. In this outcome measure, CDAI for all and non-switchers participants was reported."}, {'measure': 'Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).'}, {'measure': 'Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).'}, {'measure': 'Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).'}, {'measure': 'Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).'}, {'measure': 'Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).'}, {'measure': 'Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy', 'timeFrame': 'At month 6 follow up visit', 'description': 'mACR20 response: \\>= 20 percent (%) improvement in tender and swollen joint count and 20% improvement in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsened pain) ; 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsened condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsened function).'}, {'measure': 'Number of Participants According to Line of Therapy at TNFi Initiation', 'timeFrame': 'At baseline', 'description': 'Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of 1st line, 2nd line, 3rd line, and 4th line of therapy was reported in this outcome measure.'}, {'measure': 'Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012', 'timeFrame': 'At baseline', 'description': 'Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at TNFi initiation after 11/6/2012 was reported in this outcome measure.'}, {'measure': 'Number of Participants According to Line of Therapy at Tofacitinib Initiation', 'timeFrame': 'At baseline', 'description': 'Line of therapy: 1st line: no prior use of any DMARD at time of initiation. 2nd line: prior use of at least one convention cDMARD and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics. Number of participants according to line of therapy at tofacitinib initiation was reported in this outcome measure.'}, {'measure': 'Median CDAI Score at Baseline- TNFi Initiator', 'timeFrame': 'At baseline', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi Initiator."}, {'measure': 'Median CDAI Score at Baseline- Tofacitinib Initiator', 'timeFrame': 'At baseline', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of Tofacitinib Initiator."}, {'measure': 'Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012', 'timeFrame': 'At baseline', 'description': "CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale (VAS); higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Baseline was defined as the time of initiation of TNFi initiator after 11-6-2012."}, {'measure': 'Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation', 'timeFrame': 'At baseline', 'description': 'Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at TNFi initiation was reported in this outcome measure. Line of therapy: 1st line: no prior use of any Disease-modifying anti-rheumatic drug (DMARD) at time of initiation. 2nd line: prior use of at least one convention DMARD (cDMARD) and no prior use of any biologic. 3rd line: prior use of at least one cDMARD and prior use of 1 biologic. 4th line: prior use of at last one cDMARD and prior use of 2 or more biologics.'}, {'measure': 'Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012', 'timeFrame': 'At baseline', 'description': 'Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy (LOT): prior use of at least one biologic) use at TNFi initiation after 11/6/2012 was reported in this outcome measure.'}, {'measure': 'Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation', 'timeFrame': 'At baseline', 'description': 'Number of participants according to prior biologic for line of therapy of prior biologics (restricted to 3+ line of therapy: prior use of at least one biologic) use at tofacitinib initiation was reported in this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'To estimate the efficacy of treatment with TNFi as monotherapy or combination therapy with MTX and compare and contrast efficacy with Tofacitinib as monotherapy and combination therapy in a real world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Observational retrospective data using the Corrona RA Registry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RA patients in Corrona initiating a TNFi biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) during follow-up in Corrona with no prior use of Tofacitinib\n\nExclusion Criteria:\n\n* Patients with no history of cDMARD but history of 1+ biologics - these cases will be excluded from analyses\n* Patients using combination therapy with a cDMARD other than MTX will be excluded\n* Patients using combination therapy of MTX and another cDMARD will be excluded'}, 'identificationModule': {'nctId': 'NCT05576051', 'briefTitle': 'To Estimate the Efficacy of Treatment With TNFi as Monotherapy or Combination Therapy With MTX and Compare and Contrast Efficacy With Tofacitinib as Monotherapy and Combination Therapy in a Real World Setting.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Epidemiology and Efficacy of TNFi Combination Therapy (MTX+TNFi), TNFi Monotherapy, Tofacitinib Combination Therapy and Tofacitinib Monotherapy', 'orgStudyIdInfo': {'id': 'A3921422'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All TNFi initiations', 'interventionNames': ['Other: patterns of use of combination therapy and monotherapy']}, {'label': 'TNFi initiations after 11/6/2012 for comparisons with Tofacitinib initiators', 'interventionNames': ['Other: patterns of use of combination therapy and monotherapy']}, {'label': 'RA patient in Corrona with initiation Tofacitinib during follow-up in Corron', 'interventionNames': ['Other: patterns of use of combination therapy and monotherapy']}], 'interventions': [{'name': 'patterns of use of combination therapy and monotherapy', 'type': 'OTHER', 'armGroupLabels': ['All TNFi initiations', 'RA patient in Corrona with initiation Tofacitinib during follow-up in Corron', 'TNFi initiations after 11/6/2012 for comparisons with Tofacitinib initiators']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}