N/A
Completed N=1,972
Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT05572567 ↗
Enrolled (actual)
1,972
Serious AEs
—
Results posted
Jun 2025
Primary outcomePrimary: Mean Incidence Rate of Total Cardiovascular Disease (CVD) Events — 0.51; 0.76; 1.4; 1.54 Participants with event/100 Person years
Summary
This is a secondary structured database observational study conducted in Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs, including tofacitinib, collected as part of the CorEvitas Japan RA Registry.
The data as of September 2022 will be used for this study. The study will include data from March 2016 to the latest data cut available in 2022 for both effectiveness and safety outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Incidence Rate of Total Cardiovascular Disease (CVD) Events |
0.51; 0.76; 1.4; 1.54 | — |
| PRIMARY Mean Incidence Rate of Serious Infections Events |
1.94; 2.61; 5.02; 3.1 | — |
| PRIMARY Mean Incidence Rate of Total Herpes Zoster Events |
0.9; 1.39; 2.18; 8.07 | — |
| PRIMARY Mean Incidence Rate of Total Malignancy Excluding Non-Melanoma Skin Cancer (NMSC) |
1.72; 1.71; 1.93; 1.51 | — |
| PRIMARY Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at 6 Months |
-10.1; -10.4; -11.5; -11.7 | — |
| PRIMARY Mean Change From Baseline in Japanese Health Assessment Questionnaire (J-HAQ) at 6 Months |
-0.3; -0.2; -0.3; -0.3 | — |
| PRIMARY Mean Change From Baseline in Participant's Pain at 6 Months |
-21.7; -17.6; -17.4; -21.4 | — |
| PRIMARY Mean Change From Baseline in Participant's Fatigue at 6 Months |
-13; -9.4; -10.7; -15.5 | — |
| PRIMARY Mean Change From Baseline in Participant's Global Assessment at 6 Months |
-18.5; -16.8; -16.1; -19.5 | — |
| PRIMARY Mean Change From Baseline in Morning Stiffness at 6 Months |
-31.5; -22.4; -17.9; -19.7 | — |
| PRIMARY Change in Percentage of Participants Reporting Moderate/Severe/Extreme Difficulty Levels for EQ-5D-5L From Baseline at Month 6 |
-10.2; -6.8; -11.1; -10.8; -8.6; -7.6 | — |
| PRIMARY Percentage of Participants Who Achieved Minimally Clinically Important Difference (MCID) Improvement at 6 Months |
61.1; 57.6; 65; 65.1 | — |
| PRIMARY Percentage of Participants Who Achieved Modified American College of Rheumatology (mACR) 20 Response Score at 6 Months |
47.1; 39.8; 45.6; 44.4 | — |
| PRIMARY Percentage of Participants Who Achieved mACR 50 Response Score at 6 Months |
35.9; 29.9; 31.7; 33.2 | — |
| PRIMARY Percentage of Participants Who Achieved mACR 70 Response Score at 6 Months |
21.4; 18.2; 18.6; 22.4 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Rheumatoid Arthritis (RA) according to the 1987 American College of Rheumatology (ACR) or the ACR/European Lead Against Rheumatism (EULAR) 2010 RA Classification Criteria;
- At least 18 years of age or older;
- Was / Must be prescribed or switching to the following eligible medication for the first time ever at the enrollment visit:
- csDMARD: methotrexate (closed in February 2018);
- Anti-TNF bDMARD: adalimumab (originator or biosimilar), certolizumab pegol, etanercept (originator or biosimilar), golimumab, infliximab (originator or biosimilar), or any other anti-TNF biosimilar approved during the study;
- Non-TNF bDMARD: abatacept, tocilizumab, sarilumab (closed in June 2020);
- JAK inhibitor: tofacitinib, baricitinib, peficitinib, filgotinib, upadacitinib.
Exclusion Criteria
- Data that are prior to March 2016 and after June 2022
Data sourced from ClinicalTrials.gov (NCT05572567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.