- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04721821
Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.
October 20, 2023 updated by: Pfizer
Comparative Effectiveness of Tumor Necrosis Factor (TNF) Inhibitors and Tofacitinib, Overall, by Line of Therapy and by Combination Therapy
This study is to investigate if there has been a shift in treatment with tofacitinib, assessing real world patient data and entered in the Corrona registry between 2016 and 2020.
Study Overview
Study Type
Observational
Enrollment (Actual)
7807
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10017
- Pfizer
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Data will be collected from the Corrona RA Registry.
The Corrona RA Registry is a prospective, multicenter, observational disease-based registry.
Description
Inclusion Criteria:
- RA patients in Corrona initiating tofacitinib or a TNF biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) after 06 November 2012 (market approval of Tofacitinib) during follow-up in Corrona with no prior use of tofacitinib. Only the patient's first initiation after 06 November 2012 will be included in the analysis
- Have a 6 and / or 12-month follow-up visit (with +/- 2 month window)
- Have Clinical Disease Activity Index (CDAI) measures at baseline and at the follow-up visit
Exclusion Criteria:
- Patients who have not failed methotrexate (MTX) or another csDMARD (ie 1st line initiators)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with Rheumatoid Arthritis (RA)
|
Patients who received Tofacitinib for RA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall
Time Frame: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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 meant 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.
Achievement of LDA was defined by CDAI less than or equal to (<=)10 in participants with moderate or high disease activity CDAI greater than (>) 10 at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Month 6 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 6 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy
Time Frame: Month 6 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 6 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy
Time Frame: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
Time Frame: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall
Time Frame: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Month 12 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 12 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy
Time Frame: Month 12 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 12 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
Time Frame: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
Time Frame: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of remission was defined by CDAI (<=2.8) in those participants with LDA, moderate or high disease activity (CDAI >2.8) at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of remission was defined by CDAI (<=2.8) in those participants with LDA, moderate or high disease activity (CDAI >2.8) at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of remission was defined by CDAI (<=2.8) in those participants with LDA, moderate or high disease activity (CDAI >2.8) at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of remission was defined by CDAI (<=2.8) in those participants with LDA, moderate or high disease activity (CDAI >2.8) at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
Time Frame: Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Achievement of remission was defined by CDAI (<=2.8) in those participants with LDA, moderate or high disease activity (CDAI >2.8) at baseline.
Propensity score method was used for analysis of the outcome measure.
|
Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
Time Frame: Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Propensity score method was used for analysis of the outcome measure.
|
Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Baseline,Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Propensity score method was used for analysis of the outcome measure.
|
Baseline,Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
Time Frame: Baseline, Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Propensity score method was used for analysis of the outcome measure.
|
Baseline, Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy
Time Frame: Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Propensity score method was used for analysis of the outcome measure.
|
Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy
Time Frame: Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and 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 meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 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.
Propensity score method was used for analysis of the outcome measure.
|
Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
mACR 20/50/70 response was defined as response greater than or equal to( >=) 20 percent (%), 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the modified Health Assessment Questionnaire (mHAQ) [scored from 0 to 3, higher scores indicated worsening of function].
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
mACR 20/50/70 response was defined as response >= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
mACR 20/50/70 response was defined as response >= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
Time Frame: Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
mACR 20/50/70 response was defined as response >= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Propensity score method was used for analysis of the outcome measure.
|
Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
mACR 20/50/70 response was defined as response >= 20%, 50%, or 70% improvement in tender and swollen joint count and 20%, 50% or 70% improvement respectively in 2 of the following 4 criteria: 1) participant assessment of pain (scored from 0 to 100, higher scores indicated worsening of pain); 2) participant global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 3) physician global assessment of disease activity (scored from 0 to 100, higher scores indicated worsening of condition); 4) self-assessed disability index of the mHAQ (scored from 0 to 3, higher scores indicated worsening of function).
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour [mm/hour]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity).
DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of.
DAS28 ESR <= 3.2 = low disease activity, DAS28 ESR > 3.2 and <=5.1 = moderate and >5.1 = high disease activity.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity).
DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of.
DAS28 ESR <= 3.2 = low disease activity, DAS28 ESR > 3.2 and <=5.1 = moderate and >5.1 = high disease activity.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity).
DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of.
DAS28 ESR <= 3.2 = low disease activity, DAS28 ESR > 3.2 and <=5.1 = moderate and >5.1 = high disease activity.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity).
DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of.
DAS28 ESR <= 3.2 = low disease activity, DAS28 ESR > 3.2 and <=5.1 = moderate and >5.1 = high disease activity.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
DAS28 ESR was calculated from the number of SJC and PJC using the 28 joints count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity).
DAS 28 ESR =0.56*sqrt (PJC28) + 0.28*sqrt (SJC28) + 0.70*In (ESR) + 0.014*PtGA; ln = natural logarithm, sqrt = square root of.
DAS28 ESR <= 3.2 = low disease activity, DAS28 ESR > 3.2 and <=5.1 = moderate and >5.1 = high disease activity.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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, reaching, gripping, hygiene, and carrying out 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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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, reaching, gripping, hygiene, and carrying out 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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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, reaching, gripping, hygiene, and carrying out 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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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, reaching, gripping, hygiene, and carrying out 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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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, reaching, gripping, hygiene, and carrying out 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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
Time Frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
MCID improvement assessed based on 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 carrying out 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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
MCID improvement assessed based on 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 carrying out 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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time Frame: Baseline, Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
MCID improvement assessed based on 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 carrying out 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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline.
Propensity score method was used for analysis of the outcome measure.
|
Baseline, Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy
Time Frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
MCID improvement assessed based on 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 carrying out 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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy
Time Frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
MCID improvement assessed based on 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 carrying out 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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Achievement of MCID for the HAQ was defined as decrease in minimum of 0.22 units from baseline.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
|
Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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 possible score ranged from 0 to 3, where 0 = least difficulty and 3 = extreme difficulty, higher scores indicating worse functioning.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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.
Participants who reported VAS <= 20 mm were categorized with mild pain and were reported in this outcome measure.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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.
Participants who reported VAS <= 20 mm were categorized with mild pain and were reported in this outcome measure.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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.
Participants who reported VAS <= 20 mm were categorized with mild pain and were reported in this outcome measure.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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.
Participants who reported VAS <= 20 mm were categorized with mild pain and were reported in this outcome measure.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
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.
Participants who reported VAS <= 20 mm were categorized with mild pain and were reported in this outcome measure.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms) post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms) post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Participants assessed their fatigue using a 0 to 100 mm VAS scale, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time Frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit (for respective arms) post initiation of TNFis during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit (for respective arms) post initiation of TNFis during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
Time Frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in hours.
Propensity score method was used for analysis of the outcome measure.
|
Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 22, 2021
Primary Completion (Actual)
November 29, 2021
Study Completion (Actual)
November 29, 2021
Study Registration Dates
First Submitted
January 19, 2021
First Submitted That Met QC Criteria
January 19, 2021
First Posted (Actual)
January 25, 2021
Study Record Updates
Last Update Posted (Actual)
April 12, 2024
Last Update Submitted That Met QC Criteria
October 20, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Necrosis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Janus Kinase Inhibitors
- Tofacitinib
Other Study ID Numbers
- A3921389
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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