Arthritis RheumatoidNCT04721821
Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.
An observational study of Arthritis Rheumatoid, run by Pfizer at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Rheumatoid
- What is being tested?
- Tofacitinib
- How many people
- 7,807 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2021to 29 Nov 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data will be collected from the Corrona RA Registry. The Corrona RA Registry is a prospective, multicenter, observational disease-based registry.
Who may be able to join
- RA patients in Corrona initiating tofacitinib or a TNF biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) after 06 November 2012 (market approval of Tofacitinib) during follow-up in Corrona with no prior use of tofacitinib. Only the patient's first initiation after 06 November 2012 will be included in the analysis
- Have a 6 and / or 12-month follow-up visit (with +/- 2 month window)
- Have Clinical Disease Activity Index (CDAI) measures at baseline and at the follow-up visit
Who cannot join
- Patients who have not failed methotrexate (MTX) or another csDMARD (ie 1st line initiators)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Tumor Necrosis Factor (TNF) Inhibitors and Tofacitinib, Overall, by Line of Therapy and by Combination Therapy
This study is to investigate if there has been a shift in treatment with tofacitinib, assessing real world patient data and entered in the Corrona registry between 2016 and 2020.
- Conditions
- Arthritis Rheumatoid
- Being tested
- Tofacitinib
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Patients who received Tofacitinib for RA
| Study group | Role | What they receive |
|---|---|---|
| Patients with Rheumatoid Arthritis (RA) | Not described Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Secondary outcomes (55)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start22 Jan 2021
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthritis RheumatoidStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721821
- Sponsor's protocol ID
- A3921389
- Status last verified
- Oct 2023
- First submitted
- 19 Jan 2021
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Tumor Necrosis Factor (TNF) Inhibitors and Tofacitinib, Overall, by Line of Therapy and by Combination Therapy
- ClinicalTrials.gov ID
- NCT04721821
- Acronym / sponsor ID
- A3921389
- Conditions
- Arthritis Rheumatoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,807 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Posted 12 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to investigate if there has been a shift in treatment with tofacitinib, assessing real world patient data and entered in the Corrona registry between 2016 and 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Rheumatoid Arthritis (RA) | – | Drug: Tofacitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be collected from the Corrona RA Registry. The Corrona RA Registry is a prospective, multicenter, observational disease-based registry.
Key inclusion criteria (3 listed)
- RA patients in Corrona initiating tofacitinib or a TNF biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) after 06 November 2012 (market approval of Tofacitinib) during follow-up in Corrona with no prior use of tofacitinib. Only the patient's first initiation after 06 November 2012 will be included in the analysis
- Have a 6 and / or 12-month follow-up visit (with +/- 2 month window)
- Have Clinical Disease Activity Index (CDAI) measures at baseline and at the follow-up visit
Key exclusion criteria (1 listed)
- Patients who have not failed methotrexate (MTX) or another csDMARD (ie 1st line initiators)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TofacitinibPatients who received Tofacitinib for RA | Drug | Patients with Rheumatoid Arthritis (RA) |
Primary outcome
Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall
Time frame: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
CDAI was a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 centimeter (cm) visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI less than or equal to (<=)10 in participants with moderate or high disease activity CDAI greater than (>) 10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time frame: Month 6 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: TNFi Monotherapy Versus TNFis Combination Therapy
Time frame: Month 6 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Monotherapy Versus TNFis Combination Therapy
Time frame: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 6: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
Time frame: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Overall Versus TNFis Overall
Time frame: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time frame: Month 12 visit post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: TNFis Monotherapy Versus TNFis Combination Therapy
Time frame: Month 12 visit post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
Time frame: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline. Propensity score method was used for analysis of the outcome measure.
Number of Participants Who Achieved LDA Based on CDAI at Month 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
Time frame: Month 12 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study
CDAI was a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment, range from 0 to 28, higher scores meant worse condition), PtGA and PGA (score range from 0 to 10, assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0 (no disease) to 76 (severe disease), higher scores indicated worse condition. Achievement of LDA was defined by CDAI <=10 in participants with moderate or high disease activity CDAI>10 at baseline. Propensity score method was used for analysis of the outcome measure.
55 secondary outcomes
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants Who Achieved Remission Based on CDAI at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
Time frame: Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
Time frame: Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time frame: Baseline,Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Change From Baseline in CDAI 0-76 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
Time frame: Baseline, Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Monotherapy vs TNFis Combination Therapy
Time frame: Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
Change From Baseline in CDAI 0-76 at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy
Time frame: Baseline, Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
Number of Participants With Modified American College of Rheumatology (mACR) 20/50/70 at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants With MACR 20/50/70 at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
Time frame: Month 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants With MACR 20/50/70 at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFis Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants Who Achieved LDA Based on Disease Activity Score (DAS 28) Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time frame: Months 6 and 12 visit (for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: TNFis Monotherapy Versus TNFis Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Monotherapy Versus TNFis Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants Who Achieved LDA Based on DAS 28 ESR at Month 6 and 12: Tofacitinib Combination Therapy vs TNFis Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Health Assessment Questionnaire (HAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFis Overall
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
HAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
HAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
HAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Number of Participants Who Achieved Minimally Clinically Important Difference (MCID) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
Time frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
Number of Participants Who Achieved MCID at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time frame: Baseline, Months 6 and 12 visit (for respective arms) post initiation of TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Monotherapy vs TNFi Combination Therapy
Time frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
Number of Participants Who Achieved MCID at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy
Time frame: Months 6 and 12 visit (for respective arms) post initiation of Tofacitinib or TNFis, during observation period from 06-Nov-2012 to 28-Feb-2021 (approximately 8.3 years);data collected and studied from 22-Jan-2021 to 29-Nov-2021 in this study
Modified Health Assessment Questionnaire (mHAQ) Score at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
mHAQ Score at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
mHAQ Score at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
mHAQ Score at Month 6 and 12: Tofacitinib Combination Therapy Versus TNFi Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Pain Visual Analog Scale (VAS) at Month 6 and 12: Tofacitinib Overall Versus TNFi Overall
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus Tofacitinib Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Pain VAS at Month 6 and 12: TNFi Monotherapy Versus TNFi Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of TNFis, during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Pain VAS at Month 6 and 12: Tofacitinib Monotherapy Versus TNFi Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Pain VAS at Month 6 and 12: Tofacitinib Combination Therapy vs TNFi Combination Therapy
Time frame: Months 6 and 12 visit(for respective arms)post initiation of Tofacitinib or TNFis,during observation period from 06-November-2012 to 28-Feb-2021(approximately 8.3 years);data was collected and studied from 22-January-2021 to 29-November-2021 in this study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis Rheumatoid, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Achieved Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) at Month 6: Tofacitinib Overall Versus TNFis Overall (time frame: Month 6 visit post initiation of Tofacitinib or TNFis, during observation period from 06-November-2012 to 28-Feb-2021 (approximately 8.3 years); data was collected and studied from 22-January-2021 to 29-November-2021 in this study). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.