Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT05487703
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2022-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study To Describe The Use Of Tofacitinib After Use Of Rituximab In Patients With Rheumatoid Arthritis 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 were not planned to be collected during the study.', 'description': 'Minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not collected and reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants According to Type of Health Insurance Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'title': 'Private', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}, {'title': 'Medicare', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}, {'title': 'Medicaid', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'No Insurance', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to type of health insurance plan was reported in this outcome measure. The health insurance plan included private, Medicare, Medicaid and no insurance. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib. One participant might have more than one type of insurance.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With College Graduation or Higher Education', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants who were college graduate or had higher education were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Smoking Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'title': 'Never smoker', 'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}, {'title': 'Former smoker', 'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}, {'title': 'Current smoker', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to smoking status was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Work Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'title': 'Full time', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}, {'title': 'Part time', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Work at home', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Student', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Disabled', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}, {'title': 'Retired', 'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to work status was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Alcohol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'title': 'None/ less than (<)1 drink per week', 'measurements': [{'value': '224', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}, {'title': '1-3 drinks per week', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'title': '1-2 drinks per day', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Greater than (>) 3 drinks per day', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to alcohol use were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to History of Comorbidities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'title': 'Malignancy', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Serious Infection', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Tuberculosis (active or latent)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular Disease', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Interstitial Lung Disease (ILD/Pulmonary Fibrosis)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to history of comorbidities were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib. One participant might have more than one history of comorbidities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Duration of Rheumatoid Arthritis at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Duration of rheumatoid arthritis in participants at the time of index date was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Age at Onset of Rheumatoid Arthritis at Index Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '42.2', 'spread': '14.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Participants age at onset of rheumatoid arthritis at the time of index date was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Clinical Disease Activity Index (CDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', '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. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.", '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.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to CDAI Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'title': 'Remission (<= 2.8)', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Low (> 2.8 to <=10)', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Moderate (>10 to <= 22)', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'High (>22)', 'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to CDAI category were reported in this outcome measures. CDAI was simplified index for assessing disease activity comprising of SJC, TJC, PtGA and PGA. CDAI is numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher score indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm VAS; higher score indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher score indicated worse condition. Score range-Remission: CDAI less than or equal to (\\<=) 2.8. Low Disease Activity: CDAI greater than (\\>) 2.8 and \\<= 10. Moderate Disease Activity: CDAI \\> 10 and \\<= 22. High Disease Activity: CDAI \\> 22. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Tender Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Tender joint count was used to measure the pain and inflammation in the joints, based on 28-joint assessment range from 0 to 28, where higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Swollen Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Swollen joint count was used to measure the pain and inflammation in the joints. Based on 28-joint assessment range from 0 to 28, where higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Patient Global Assessment (PGA) VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '51.4', 'spread': '25.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'PGA-VAS was used to assess disease activity; assessed on 0-100 millimeter (mm) VAS; higher scores indicated greater affection due to disease activity. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Modified Health Assessment Questionnaire (mHAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicated worse functioning. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', '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.'}, {'type': 'PRIMARY', 'title': 'Pain VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '27.0', 'groupId': 'OG000'}, {'value': '57.1', 'spread': '26.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Pain VAS was assessed using 100 millimeter (mm) horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Fatigue VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '57.3', 'spread': '29.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Domain Scores of 2 or Higher', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'title': 'Walking', 'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}]}, {'title': 'Self-care', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Usual activities', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}, {'title': 'Pain and discomfort', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety and depression', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'EQ-5D-3L is a health profile questionnaire used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (walking, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems in the 5 dimensions, where higher score indicated more severe problems. In this outcome measure number of participants with a domain score of 2 or higher in each individual domain are reported. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Previous Drug Therapies With Conventional Disease-Modifying Antirheumatic Drug (csDMARD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'title': '0 previous csDMARD', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': '1 previous csDMARD', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': '>= 2 previous csDMARD', 'measurements': [{'value': '242', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to previous drug therapies with csDMARD were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Line of Therapy at Tofacitinib Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'title': '2 prior biologics (Rituximab (RTX) + 1 other biologic)', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': '3 prior biologics (RTX + 2 other biologics)', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': '4 prior biologics (RTX + 3 other biologics)', 'measurements': [{'value': '291', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants were classified according to line of therapy in which Tofacitinib was initiated and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Concomitant Therapies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'title': 'Monotherapy', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Combination with Methotrexate (MTX) only', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Combination with nonMTX csDMARD only', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Combination with MTX & nonMTX csDMARD', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Prednisone', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants classified according to concomitant therapies were reported in this outcome measure. One participant might have received more than one concomitant therapy. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Used Rituximab (RTX) Directly Before Tofacitinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Percentage of participants who used rituximab directly before tofacitinib were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Duration of Prior Rituximab (RTX) Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '24.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Duration of prior RTX use (in months) was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Line of Therapy at Rituximab Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'title': '2 prior biologics (other biologic + Rituximab [RTX])', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': '3 prior biologics (2 other biologics + RTX)', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'title': '4 prior biologics (3 other biologic + RTX)', 'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants were classified according to line of therapy in which Rituximab was initiated were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Year of Rituximab Discontinuations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'title': '2006-2007', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': '2008-2009', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': '2010-2011', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'title': '2012-2013', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': '2014-2015', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': '2016-2017', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': '2018-2019', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': '2020-2022', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants were classified according to year of rituximab discontinuations and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Percentage of participants who discontinued rituximab were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Reason for Discontinuation of Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}], 'classes': [{'categories': [{'title': 'Effectiveness', 'measurements': [{'value': '60', 'groupId': 'OG000'}]}, {'title': 'Physician Decision', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Insurance', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Participant doing well', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Other Reasons', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants were classified according to reasons for discontinuation of rituximab and were reported in this outcome measure. Reasons for discontinuation of rituximab included safety, effectiveness, insurance, participant doing well and other reasons. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all eligible participants whose medical records were retrieved and observed in this study. Here ''Number of Participants Analyzed'' signifies number of participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in tofacitinib group."}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Tofacitinib Initiation Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}, {'id': 'OG001', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'title': '2012-2013', 'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}, {'title': '2014-2015', 'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': '2016-2017', 'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': '2018-2019', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': '2020-2022', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants were classified according to year of tofacitinib initiation and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in CDAI at 6 Months Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'title': 'At baseline', 'categories': [{'measurements': [{'value': '22.53', 'spread': '14.04', 'groupId': 'OG000'}]}]}, {'title': 'At 6 Months', 'categories': [{'measurements': [{'value': '19.08', 'spread': '14.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])', '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; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved, observed in this study and who had completed 6-month follow up visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Minimum Clinically Important Difference (MCID) at 6 Month Follow Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '22.7', 'upperLimit': '35.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])', 'description': 'MCID improvement was assessed based on health assessment questionnaire (HAQ). HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and conducting daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total score ranged from 0 to 3, where 0= least difficulty and 3= extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for HAQ was defined as decrease in minimum of 0.22 units from baseline. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved, observed in this study and who had completed 6-month follow up visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'title': 'At baseline', 'categories': [{'measurements': [{'value': '1.35', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'At 6 Months', 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])', 'description': 'HAQ: self-reported, valid assessment of functional disability in RA. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, hygiene, reaching, griping, and conducting daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved, observed in this study and who had completed 6-month follow up visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain VAS at 6 Months Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'title': 'At baseline', 'categories': [{'measurements': [{'value': '57.16', 'spread': '26.74', 'groupId': 'OG000'}]}]}, {'title': 'At 6 Months', 'categories': [{'measurements': [{'value': '51.27', 'spread': '27.80', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])', 'description': 'Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved, observed in this study and who had completed 6-month follow up visit.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fatigue VAS at 6 Months Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tofacitinib: Subset With 6-month Visit', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 and with 6-month visit were included in this reporting group.'}], 'classes': [{'title': 'At baseline', 'categories': [{'measurements': [{'value': '57.39', 'spread': '29.19', 'groupId': 'OG000'}]}]}, {'title': 'At 6 Months', 'categories': [{'measurements': [{'value': '54.75', 'spread': '29.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])', 'description': 'Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all eligible participants whose medical records were retrieved, observed in this study and who had completed 6-month follow up visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '318'}]}, {'type': 'Subset With 6 Month Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Participant not well', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Insurance Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}]}]}], 'recruitmentDetails': 'Participants diagnosed with rheumatoid arthritis (RA), enrolled in CorEvitas RA Registry, initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012, were included in this study.', 'preAssignmentDetails': 'Total 3190 participants were screened, out of which 2872 participants did not met the inclusion criteria and only 318 participants were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tofacitinib', 'description': 'Participants diagnosed with RA, enrolled in CorEvitas RA registry who initiated tofacitinib with a history of rituximab use on or after 06-Nov-2012 were included in this reporting group. Duration of data collection for this study was from 06-Nov-2012 to 31-Oct-2022 (approximately 9 years).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59.9', 'spread': '11.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '262', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '277', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '"Number Analyzed" refers to number of participants, with available data for this measure.'}, {'title': 'Body Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '86.0', 'spread': '22.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI) Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'BG000'}]}], 'categories': [{'title': 'BMI (kg/m^2) <25', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': 'BMI (kg/m^2) 25.0 to <30', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'BMI (kg/m^2) >=30', 'measurements': [{'value': '169', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Body Mass Index (BMI) was classified as Normal or underweight which indicated participants with BMI (kg/m\\^2) less than 25 (\\<25), Overweight which indicated participants with BMI (kg/m\\^2) from 25 to less than 30 (25-\\<30) and obese which indicated participants with BMI (kg/m\\^2) greater than or equal to 30 (\\>=30).', 'unitOfMeasure': 'Participants', 'populationDescription': '"Number Analyzed" refers to number of participants, with available data for this measure.'}], 'populationDescription': 'Analysis population included all eligible participants whose data were observed in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-13', 'size': 270820, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-06T16:42', 'hasProtocol': True}, {'date': '2023-05-04', 'size': 397486, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-06T16:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-05', 'studyFirstSubmitDate': '2022-08-02', 'resultsFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-05', 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants According to Type of Health Insurance Plan', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to type of health insurance plan was reported in this outcome measure. The health insurance plan included private, Medicare, Medicaid and no insurance. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib. One participant might have more than one type of insurance.'}, {'measure': 'Number of Participants With College Graduation or Higher Education', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants who were college graduate or had higher education were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to Smoking Status', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to smoking status was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to Work Status', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to work status was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to Alcohol Use', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to alcohol use were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to History of Comorbidities', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to history of comorbidities were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib. One participant might have more than one history of comorbidities.'}, {'measure': 'Duration of Rheumatoid Arthritis at Index Date', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Duration of rheumatoid arthritis in participants at the time of index date was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Age at Onset of Rheumatoid Arthritis at Index Date', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Participants age at onset of rheumatoid arthritis at the time of index date was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Clinical Disease Activity Index (CDAI)', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', '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. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib."}, {'measure': 'Number of Participants According to CDAI Categories', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to CDAI category were reported in this outcome measures. CDAI was simplified index for assessing disease activity comprising of SJC, TJC, PtGA and PGA. CDAI is numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher score indicated worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm VAS; higher score indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher score indicated worse condition. Score range-Remission: CDAI less than or equal to (\\<=) 2.8. Low Disease Activity: CDAI greater than (\\>) 2.8 and \\<= 10. Moderate Disease Activity: CDAI \\> 10 and \\<= 22. High Disease Activity: CDAI \\> 22. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Tender Joint Count', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Tender joint count was used to measure the pain and inflammation in the joints, based on 28-joint assessment range from 0 to 28, where higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Swollen Joint Count', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Swollen joint count was used to measure the pain and inflammation in the joints. Based on 28-joint assessment range from 0 to 28, where higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Patient Global Assessment (PGA) VAS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'PGA-VAS was used to assess disease activity; assessed on 0-100 millimeter (mm) VAS; higher scores indicated greater affection due to disease activity. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Modified Health Assessment Questionnaire (mHAQ)', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'mHAQ is the modified version of HAQ which simplifies it from 20 questions to 8 questions, which assessed the ability to perform tasks due to rheumatoid arthritis. It comprised of 8 questions on 8 categories of daily living activities: dress/groom; arise; eat; grip; walk; hygiene; reach; and common activities over past week before specified time point. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicated worse functioning. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Pain VAS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Pain VAS was assessed using 100 millimeter (mm) horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Fatigue VAS', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants With European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Domain Scores of 2 or Higher', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'EQ-5D-3L is a health profile questionnaire used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (walking, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems in the 5 dimensions, where higher score indicated more severe problems. In this outcome measure number of participants with a domain score of 2 or higher in each individual domain are reported. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to Previous Drug Therapies With Conventional Disease-Modifying Antirheumatic Drug (csDMARD)', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants according to previous drug therapies with csDMARD were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to Line of Therapy at Tofacitinib Initiation', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants were classified according to line of therapy in which Tofacitinib was initiated and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to Concomitant Therapies', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants classified according to concomitant therapies were reported in this outcome measure. One participant might have received more than one concomitant therapy. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Percentage of Participants Who Used Rituximab (RTX) Directly Before Tofacitinib', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Percentage of participants who used rituximab directly before tofacitinib were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Duration of Prior Rituximab (RTX) Use', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Duration of prior RTX use (in months) was reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to Line of Therapy at Rituximab Initiation', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants were classified according to line of therapy in which Rituximab was initiated were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to Year of Rituximab Discontinuations', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants were classified according to year of rituximab discontinuations and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Percentage of Participants Who Discontinued Rituximab', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Percentage of participants who discontinued rituximab were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to Reason for Discontinuation of Rituximab', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants were classified according to reasons for discontinuation of rituximab and were reported in this outcome measure. Reasons for discontinuation of rituximab included safety, effectiveness, insurance, participant doing well and other reasons. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Number of Participants According to Tofacitinib Initiation Year', 'timeFrame': 'At index date, index date could be anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years (data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month)', 'description': 'Number of participants were classified according to year of tofacitinib initiation and were reported in this outcome measure. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Change From Baseline in CDAI at 6 Months Follow-up', 'timeFrame': 'Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])', '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; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Minimum Clinically Important Difference (MCID) at 6 Month Follow Up', 'timeFrame': 'Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])', 'description': 'MCID improvement was assessed based on health assessment questionnaire (HAQ). HAQ: self-reported, valid assessment of functional disability in RA. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and conducting daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0= without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total score ranged from 0 to 3, where 0= least difficulty and 3= extreme difficulty, higher scores indicating worse functioning. Achievement of MCID for HAQ was defined as decrease in minimum of 0.22 units from baseline. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire (HAQ) at 6 Months Follow-up', 'timeFrame': 'Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])', 'description': 'HAQ: self-reported, valid assessment of functional disability in RA. The 20-question instrument assessed ability of participants to perform daily activities in 8 functional areas: dressing, arising, eating, walking, hygiene, reaching, griping, and conducting daily activities. Eight items were rated on a 4-point Likert scale from 0 to 3, where 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Change From Baseline in Pain VAS at 6 Months Follow-up', 'timeFrame': 'Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])', 'description': 'Pain VAS was assessed using 100 mm horizontal line to rate pain. Score ranged from 0 mm to 100 mm; where, 0 = no pain and 100 = worst possible pain. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}, {'measure': 'Change From Baseline in Fatigue VAS at 6 Months Follow-up', 'timeFrame': 'Baseline, Month 6 follow up visit (anytime during observation period from 06-Nov-2012 to 31-Oct-2022, approximately 9 years [data was observed retrospectively in this study from 14-Nov-2022 to 23-Dec-2022, for approximately 1 month])', 'description': 'Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Index date was defined as the date of tofacitinib initiation at or after enrollment in the registry; initiation was defined as first ever use of tofacitinib.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A3921420', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is to characterize the use of tofacitinib after use of rituximab in patients with Rheumatoid Arthritis in a real-world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This will be a retrospective analysis of participants data using the CorEvitas RA Registry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled in the CorEvitas RA Registry and initiated tofacitinib on or after November 2012.\n* Initiate tofacitinib (defined as first ever use of tofacitinib) at Registry enrollment visit or at a Registry follow-up visit after November 2012\n* Have prior use of rituximab\n* Have CDAI measured at baseline and appropriate follow-up visit.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this study'}, 'identificationModule': {'nctId': 'NCT05487703', 'briefTitle': 'A Study To Describe The Use Of Tofacitinib After Use Of Rituximab In Patients With Rheumatoid Arthritis In A Real-World Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Tofacitinib Use in Rituximab-Experienced RA Patients', 'orgStudyIdInfo': {'id': 'A3921420'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical characteristics', 'description': 'clinical characteristics of adult patients with Rheumatoid Arthritis (RA) initiating tofacitinib'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Casablanca', 'country': 'Morocco', 'facility': 'Pfizer', 'geoPoint': {'lat': 33.58831, 'lon': -7.61138}}], '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'}}}}