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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Rheumatoid Arthritis (RA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib | Drug | Patients who received Tofacitinib for RA |
|
| 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Data will be collected from the Corrona RA Registry. The Corrona RA Registry is a prospective, multicenter, observational disease-based registry.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10017 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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Data was collected retrospectively for observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years). Data from eligible participants for aforesaid observation period were retrieved and observed in this retrospective study from 22-January-2021 to 29-November-2021 (approximately 10 months).
Data of participants diagnosed with rheumatoid arthritis (RA), enrolled in Corrona RA registry, initiated tofacitinib or tumor necrosis factor inhibitors (TNFis) on or after 06-November-2012, after failure with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) treatment, were included.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib (6-Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm. |
| FG001 | TNFis (6-Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm. |
| FG002 | Tofacitinib (12-Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm. |
| FG003 | TNFis (12-Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose data were observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib (6-Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm. |
| BG001 | TNFis (6-Month Follow-up) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI>10) at baseline. | Posted | Count of Participants | Participants | 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 |
Not applicable as adverse events were not planned to be collected during the study
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib (6 Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2022 | Nov 14, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 27, 2020 | Nov 14, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm. |
| BG002 | Tofacitinib (12-Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm. |
| BG003 | TNFis (12-Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | "Number Analyzed" refers to those participants whose data was available and is reported. Data for remaining participants was missing and not reported. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary | Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity CDAI >10 at baseline. | Posted | Count of Participants | Participants | 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 |
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| Primary | Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI>10) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Primary | Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI>10) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Primary | Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI>10) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Primary | Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI>10) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Primary | Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI>10) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Primary | Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI>10) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Primary | Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI>10) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Primary | Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had moderate or high disease activity (CDAI>10) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI >2.8) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI >2.8) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI >2.8) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI >2.8) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and had LDA, moderate or high disease activity (CDAI >2.8) at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
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| Secondary | 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 | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR >3.2 at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR >3.2 at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR >3.2 at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR >3.2 at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms and DAS28 ESR >3.2 at baseline. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
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| Secondary | Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
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| Secondary | mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Units on a scale | 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 |
|
|
|
|
| Secondary | Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Millimeter | 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 |
|
|
|
|
| Secondary | Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Millimeter | 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 |
|
|
|
|
| Secondary | Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Millimeter | 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 |
|
|
|
|
| Secondary | Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Millimeter | 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 |
|
|
|
|
| Secondary | Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Millimeter | 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 |
|
|
|
|
| Secondary | Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
|
|
|
|
| Secondary | Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
|
|
|
|
| Secondary | Number of Participants Who Experienced Mild Pain at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
|
|
|
|
| Secondary | Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
|
|
|
|
| Secondary | Number of Participants Who Experienced Mild Pain at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Count of Participants | Participants | 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 |
|
|
|
|
| Secondary | Fatigue VAS at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Millimeter | 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 |
|
|
|
|
| Secondary | Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Millimeter | 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 |
|
|
|
|
| Secondary | Fatigue VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Millimeter | 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 |
|
|
|
|
| Secondary | Fatigue VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Millimeter | 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 |
|
|
|
|
| Secondary | Fatigue VAS at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Millimeter | 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 |
|
|
|
|
| Secondary | Morning Stiffness Duration at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Hours | 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 |
|
|
|
|
| Secondary | Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Hours | 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 |
|
|
|
|
| Secondary | Morning Stiffness Duration at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Hours | 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 |
|
|
|
|
| Secondary | Morning Stiffness Duration at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Hours | 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 |
|
|
|
|
| Secondary | Morning Stiffness Duration at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy | 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. | Eligible participants whose data were observed in this study. Here for this outcome measure analysis, "Overall Number of Participants Analyzed" refers to evaluable participants who were matched using propensity score method for respective reporting arms. | Posted | Mean | Standard Deviation | Hours | 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 |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | TNFis (6 Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 6-month follow-up post initiation, were included in this reporting arm. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Tofacitinib (12 Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated tofacitinib after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | TNFis (12 Month Follow-up) | Participants diagnosed with RA, enrolled in Coronna RA registry who initiated TNFis (adalimumab, etanercept, infliximab, golimumab, or certolizumab pegol) after 06-November-2012 and had at least 12-month follow-up post initiation, were included in this reporting arm. | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Male |
|
| Hispanic |
|
| Black |
|
| Asian |
|
| Other |
|
| Missing |
|
| Odds Ratio (OR) |
| 1.11 |
| 2-Sided |
| 95 |
| 0.75 |
| 1.65 |
| Superiority |
| Odds Ratio (OR) |
| 0.92 |
| 2-Sided |
| 95 |
| 0.49 |
| 1.75 |
| Superiority |
| Odds Ratio (OR) |
| 0.90 |
| 2-Sided |
| 95 |
| 0.60 |
| 1.35 |
| Superiority |
| Odds Ratio (OR) |
| 1.49 |
| 2-Sided |
| 95 |
| 0.82 |
| 2.71 |
| Superiority |
| Odds Ratio (OR) |
| 0.90 |
| 2-Sided |
| 95 |
| 0.50 |
| 1.62 |
| Superiority |
| Mean Difference (Net) |
| -1.50 |
| 2-Sided |
| 95 |
| -2.73 |
| -0.27 |
| Superiority |
| Median Difference (Net) |
| 0.96 |
| 2-Sided |
| 95 |
| -0.92 |
| 2.84 |
| Superiority |
| Mean Difference (Net) |
| 0.74 |
| 2-Sided |
| 95 |
| -0.51 |
| 1.99 |
| Superiority |
| Mean Difference (Net) |
| -1.73 |
| 2-Sided |
| 95 |
| -3.52 |
| 0.05 |
| Superiority |
| Mean Difference (Net) |
| -0.99 |
| 2-Sided |
| 95 |
| -2.60 |
| 0.62 |
| Superiority |
| mACR 50 |
|
| mACR 70 |
|
| Odds Ratio (OR) |
| 1.20 |
| 2-Sided |
| 95 |
| 0.86 |
| 1.67 |
| Superiority |
| Month 6 follow-up visit analysis: mACR 70 | Odds Ratio (OR) | 0.93 | 2-Sided | 95 | 0.57 | 1.54 | Superiority |
| Month 12 follow-up visit analysis: mACR 20 | Odds Ratio (OR) | 1.04 | 2-Sided | 95 | 0.77 | 1.41 | Superiority |
| Month 12 follow-up visit analysis: mACR 50 | Odds Ratio (OR) | 1.32 | 2-Sided | 95 | 0.89 | 1.95 | Superiority |
| Month 12 follow-up visit analysis: mACR 70 | Odds Ratio (OR) | 1.49 | 2-Sided | 95 | 0.85 | 2.60 | Superiority |
| mACR 50 |
|
| mACR 70 |
|
| Odds Ratio (OR) |
| 0.67 |
| 2-Sided |
| 95 |
| 0.39 |
| 1.15 |
| Superiority |
| Month 6 follow-up visit analysis: mACR 70 | Odds Ratio (OR) | 0.79 | 2-Sided | 95 | 0.34 | 1.83 | Superiority |
| Month 12 follow-up visit analysis: mACR 20 | Odds Ratio (OR) | 0.89 | 2-Sided | 95 | 0.56 | 1.42 | Superiority |
| Month 12 follow-up visit analysis: mACR 50 | Odds Ratio (OR) | 0.91 | 2-Sided | 95 | 0.46 | 1.80 | Superiority |
| Month 12 follow-up visit analysis: mACR 70 | Odds Ratio (OR) | 0.54 | 2-Sided | 95 | 0.19 | 1.48 | Superiority |
| mACR 50 |
|
| mACR 70 |
|
| Odds Ratio (OR) |
| 0.92 |
| 2-Sided |
| 95 |
| 0.67 |
| 1.26 |
| Superiority |
| Month 6 follow-up visit analysis: mACR 70 | Odds Ratio (OR) | 0.69 | 2-Sided | 95 | 0.44 | 1.09 | Superiority |
| Month 12 follow-up visit analysis: mACR 20 | Odds Ratio (OR) | 1.01 | 2-Sided | 95 | 0.74 | 1.38 | Superiority |
| Month 12 follow-up visit analysis: mACR 50 | Odds Ratio (OR) | 1.03 | 2-Sided | 95 | 0.69 | 1.52 | Superiority |
| Month 12 follow-up visit analysis: mACR 70 | Odds Ratio (OR) | 0.78 | 2-Sided | 95 | 0.46 | 1.33 | Superiority |
| mACR 50 |
|
| mACR 70 |
|
| Odds Ratio (OR) |
| 1.17 |
| 2-Sided |
| 95 |
| 0.71 |
| 1.95 |
| Superiority |
| Month 6 follow-up visit analysis: mACR 70 | Odds Ratio (OR) | 1.04 | 2-Sided | 95 | 0.45 | 2.39 | Superiority |
| Month 12 follow-up visit analysis: mACR 20 | Odds Ratio (OR) | 0.84 | 2-Sided | 95 | 0.50 | 1.40 | Superiority |
| Month 12 follow-up visit analysis: mACR 50 | Odds Ratio (OR) | 0.95 | 2-Sided | 95 | 0.49 | 1.83 | Superiority |
| Month 12 follow-up visit analysis: mACR 70 | Odds Ratio (OR) | 0.80 | 2-Sided | 95 | 0.33 | 1.95 | Superiority |
| mACR 50 |
|
| mACR 70 |
|
| Odds Ratio (OR) |
| 0.87 |
| 2-Sided |
| 95 |
| 0.55 |
| 1.37 |
| Superiority |
| Month 6 follow-up visit analysis: mACR 70 | Odds Ratio (OR) | 0.62 | 2-Sided | 95 | 0.32 | 1.20 | Superiority |
| Month 12 follow-up visit analysis: mACR 20 | Odds Ratio (OR) | 0.88 | 2-Sided | 95 | 0.59 | 1.30 | Superiority |
| Month 12 follow-up visit analysis: mACR 50 | Odds Ratio (OR) | 1.10 | 2-Sided | 95 | 0.65 | 1.86 | Superiority |
| Month 12 follow-up visit analysis: mACR 70 | Odds Ratio (OR) | 1.43 | 95 | 0.62 | 3.28 | Superiority |
| Odds Ratio (OR) |
| 1.12 |
| 2-Sided |
| 95 |
| 0.68 |
| 1.84 |
| Superiority |
| Odds Ratio (OR) |
| 1.38 |
| 2-Sided |
| 95 |
| 0.62 |
| 3.07 |
| Superiority |
| Odds Ratio (OR) |
| 1.05 |
| 2-Sided |
| 95 |
| 0.64 |
| 1.74 |
| Superiority |
| Odds Ratio (OR) |
| 1.72 |
| 2-Sided |
| 95 |
| 0.76 |
| 3.87 |
| Superiority |
| Odds Ratio (OR) |
| 1.18 |
| 2-Sided |
| 95 |
| 0.63 |
| 2.23 |
| Superiority |
| Mean Difference (Final Values) |
| 0.04 |
| 2-Sided |
| 95 |
| -0.01 |
| 0.09 |
| Superiority |
| Median Difference (Final Values) |
| -0.03 |
| 2-Sided |
| 95 |
| -0.11 |
| 0.05 |
| Superiority |
| Odds Ratio (OR) |
| 0.01 |
| 2-Sided |
| 95 |
| -0.05 |
| 0.07 |
| Superiority |
| Mean Difference (Final Values) |
| -0.03 |
| 2-Sided |
| 95 |
| -0.12 |
| 0.06 |
| Superiority |
| Odds Ratio (OR) |
| 0.02 |
| 2-Sided |
| 95 |
| -0.06 |
| 0.09 |
| Superiority |
| Odds Ratio (OR) |
| 0.71 |
| 2-Sided |
| 95 |
| 0.54 |
| 0.94 |
| Superiority |
| Odds Ratio (OR) |
| 1.08 |
| 2-Sided |
| 95 |
| 0.72 |
| 1.61 |
| Superiority |
| Odds Ratio (OR) |
| 1.04 |
| 2-Sided |
| 95 |
| 0.77 |
| 1.39 |
| Superiority |
| Odds Ratio (OR) |
| 1.07 |
| 2-Sided |
| 95 |
| 0.69 |
| 1.64 |
| Superiority |
| Odds Ratio (OR) |
| 0.93 |
| 2-Sided |
| 95 |
| 0.65 |
| 1.32 |
| Superiority |
| Mean Difference (Final Values) |
| 0.01 |
| 2-Sided |
| 95 |
| -0.04 |
| 0.05 |
| Superiority |
| Mean Difference (Final Values) |
| -0.01 |
| 2-Sided |
| 95 |
| -0.07 |
| 0.06 |
| Superiority |
| Mean Difference (Final Values) |
| 0.00 |
| 2-Sided |
| 95 |
| -0.04 |
| 0.04 |
| Superiority |
| Mean Difference (Final Values) |
| -0.03 |
| 2-Sided |
| 95 |
| -0.10 |
| 0.03 |
| Superiority |
| Mean Difference (Final Values) |
| -0.00 |
| 2-Sided |
| 95 |
| -0.06 |
| 0.06 |
| Superiority |
| Mean Difference (Final Values) |
| 0.26 |
| 2-Sided |
| 95 |
| -2.59 |
| 3.11 |
| Superiority |
| Mean Difference (Final Values) |
| -1.09 |
| 2-Sided |
| 95 |
| -5.12 |
| 2.95 |
| Superiority |
| Mean Difference (Final Values) |
| -0.59 |
| 2-Sided |
| 95 |
| -3.61 |
| 2.42 |
| Superiority |
| Mean Difference (Final Values) |
| -4.84 |
| 2-Sided |
| 95 |
| -9.19 |
| -0.48 |
| Superiority |
| Mean Difference (Final Values) |
| 0.76 |
| 2-Sided |
| 95 |
| -2.97 |
| 4.49 |
| Superiority |
| Odds Ratio (OR) |
| 0.94 |
| 2-Sided |
| 95 |
| 0.66 |
| 1.34 |
| Superiority |
| Odds Ratio (OR) |
| 0.90 |
| 2-Sided |
| 95 |
| 0.50 |
| 1.60 |
| Superiority |
| Odds Ratio (OR) |
| 0.87 |
| 2-Sided |
| 95 |
| 0.60 |
| 1.26 |
| Superiority |
| Odds Ratio (OR) |
| 0.84 |
| 2-Sided |
| 95 |
| 0.47 |
| 1.51 |
| Superiority |
| Odds Ratio (OR) |
| 0.91 |
| 2-Sided |
| 95 |
| 0.56 |
| 1.50 |
| Superiority |
| Mean Difference (Final Values) |
| -0.01 |
| 2-Sided |
| 95 |
| -2.79 |
| 2.77 |
| Superiority |
| Mean Difference (Final Values) |
| 1.06 |
| 2-Sided |
| 95 |
| -2.85 |
| 4.96 |
| Superiority |
| Median Difference (Final Values) |
| -0.53 |
| 2-Sided |
| 95 |
| -3.54 |
| 2.47 |
| Superiority |
| Mean Difference (Final Values) |
| -3.15 |
| 2-Sided |
| 95 |
| -7.36 |
| 1.07 |
| Superiority |
| Mean Difference (Final Values) |
| 1.01 |
| 2-Sided |
| 95 |
| -2.69 |
| 4.71 |
| Superiority |
| Mean Difference (Final Values) |
| 0.12 |
| 2-Sided |
| 95 |
| -0.21 |
| 0.45 |
| Superiority |
| Mean Difference (Final Values) |
| -0.23 |
| 2-Sided |
| 95 |
| -0.74 |
| 0.29 |
| Superiority |
| Mean Difference (Final Values) |
| -0.05 |
| 2-Sided |
| 95 |
| -0.42 |
| 0.31 |
| Superiority |
| Mean Difference (Final Values) |
| -0.19 |
| 2-Sided |
| 95 |
| -0.69 |
| 0.31 |
| Superiority |
| Mean Difference (Final Values) |
| 0.15 |
| 2-Sided |
| 95 |
| -0.30 |
| 0.59 |
| Superiority |