Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

An Observational Study Within the CorEvitas Registry to Evaluate Safety and Effectiveness of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs (bDMARDs) in Japan Among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis

ClinicalTrials.gov ID

NCT05572567

Acronym / sponsor ID

A3921429

Conditions

Arthritis, Rheumatoid

Study type

Observational

Recruitment status

Completed

Enrolment

1,972 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

10 Oct 2022 (actual)

Primary completion

10 Oct 2022 (actual)

Study completion

10 Oct 2022 (actual)

First posted

7 Oct 2022 (actual)

Results

Posted 8 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Retrospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Participants in an existing registry database

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

1. Mean Incidence Rate of Total Cardiovascular Disease (CVD) Events

   Time frame: Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)

   Incidence rate was defined as participants with total CVD events per (/) 100 person years. Total CVD was defined as hypertension requiring hospitalization, cardiac revascularization procedure (CABG, stent, angioplasty), ventricular arrhythmia, cardiac arrest, myocardial infarction, acute coronary syndrome, unstable angina, congestive heart failure (CHF) requiring hospitalization, stroke, transient ischemic attack, other cardiovascular event (specify), deep vein thrombosis, peripheral arterial thromboembolic event, urgent peripheral arterial revascularization, peripheral ischemia or gangrene (necrosis) and pulmonary embolism. Index visit was defined as the initiation date of the therapy of interest. Mean of incidence rate of total CVD events was calculated and reported.

2. Mean Incidence Rate of Serious Infections Events

   Time frame: Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)

   Incidence rate was defined as mean number of participants with serious infection events per 100 person years. Total serious infections were defined as infections meeting serious adverse event criteria or which required treatment with intravenous (IV) antibiotics. Serious infection types collected in the registry were pneumonia, sepsis, joint/bursa, cellulitis/skin, sinusitis, diverticulitis, bronchitis, gastroenteritis, meningitis/encephalitis, urinary tract infection, upper respiratory infection, active tuberculosis and other serious infections. Mean of incidence rate of total serious infection events was calculated and reported.

3. Mean Incidence Rate of Total Herpes Zoster Events

   Time frame: Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)

   Incidence rate was defined as mean number of participants with total Herpes Zoster events per 100 person years. Total herpes zoster included both serious and non-serious herpes zoster events. Mean of incidence rate of total herpes zoster events was calculated and reported.

4. Mean Incidence Rate of Total Malignancy Excluding Non-Melanoma Skin Cancer (NMSC)

   Time frame: Retrospective data collection from index visit date up to follow-up or latest data cut on 30 June 2022 (Approximately up to 75 months)

   Incidence rate (number of participants with event per 100 person year) was defined as the mean number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Total malignancy excluding non-melanoma skin cancer included lymphoma, lung cancer, breast cancer, skin cancer (melanoma), and other cancers. Mean of incidence rate of total malignancy excluding non-melanoma skin cancer was calculated and reported.

5. Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at 6 Months

   Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

   CDAI was the numerical sum of four outcome parameters: Tender joint count (TJC) or swollen joint count (SJC) both based on a 28-joint assessment, participant's assessment (PtGA) of disease activity and physician's global assessment (PGA) of disease activity both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicated greater affection due to disease activity). CDAI total score ranged from 0 to 76. Higher scores indicated greater affection due to disease activity. CDAI less than or equal to (<=) 2.8 indicated disease remission, greater than (>) 2.8 to 10 indicated low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicated high disease activity. Mean change from baseline was calculated by subtracting the baseline value from the 6-month value.

6. Mean Change From Baseline in Japanese Health Assessment Questionnaire (J-HAQ) at 6 Months

   Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

   HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. Higher scores indicated worse functioning. Mean change from baseline was calculated by subtracting the baseline value from the 6-month value.

7. Mean Change From Baseline in Participant's Pain at 6 Months

   Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

   Participants were asked the following question to answer on a numeric rating scale (NRS): "How much pain have you had because of your arthritis in the past week?" The scale ranged from 0-100, where 0=no pain and 100=pain as bad as it could be. Higher scores indicated worsening of condition. Mean change from baseline in participant's pain was calculated and reported.

8. Mean Change From Baseline in Participant's Fatigue at 6 Months

   Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

   Visual Analogue Scale (VAS) was a standardized tool for measuring overall health. Participants recorded their fatigue score on a range of 0 to 100, where higher score indicated higher intensity of fatigue. Mean change from baseline in participant's fatigue was calculated and reported.

9. Mean Change From Baseline in Participant's Global Assessment at 6 Months

   Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

   Participant's global assessment of disease activity on a 100 millimeter (mm) Visual Analog Scale (VAS) (scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicated worse health condition). Mean change from baseline was calculated by subtracting the baseline value from the 6-month value.

10. Mean Change From Baseline in Morning Stiffness at 6 Months

    Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

    CDAI and other continuous measures like morning stiffness were represented as mean change from baseline to 6-months and were calculated by subtracting the baseline value from the 6-month value.

11. Change in Percentage of Participants Reporting Moderate/Severe/Extreme Difficulty Levels for EQ-5D-5L From Baseline at Month 6

    Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

    EQ-5D-5L was a participant rated questionnaire to assess health-related quality of life. It assessed level of current health in 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each domain had 5 levels: 1= no problems, 2=slight problems, 3=moderate problems, 4=severe problems, or 5=extreme problems/unable to do task. Total score for each domain was from 1-5, where higher levels/scores indicated more difficulty in each domain. At baseline and 6 months, percentage of participants who recorded "moderate", "severe" or "extreme problems" level in each of the domain were assessed; then change was calculated in percentage of participants from baseline at Month 6 and was reported in this outcome measure.

12. Percentage of Participants Who Achieved Minimally Clinically Important Difference (MCID) Improvement at 6 Months

    Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

    MCID improvement assessed based on CDAI. CDAI: numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; CDAI total score = 0-76, higher scores=greater affection due to disease activity (DA). CDAI <= 2.8 indicates disease remission, > 2.8 to 10 = low DA, >10 to 22 = moderate DA, and >22 = high DA. MCID improvement defined by difference in CDAI from baseline (at time of tofacitinib initiation) to 6-month visit.

13. Percentage of Participants Who Achieved Modified American College of Rheumatology (mACR) 20 Response Score at 6 Months

    Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

    mACR20 response: >= 20 percent (%) improvement in tender and swollen joint count and 20% improvement 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 j-HAQ (scored from 0 to 3, higher scores indicated worsening of function).

14. Percentage of Participants Who Achieved mACR 50 Response Score at 6 Months

    Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

    mACR50 response: >= 50% improvement in tender and swollen joint count and 50% improvement 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 j-HAQ (scored from 0 to 3, higher scores indicated worsening of function).

15. Percentage of Participants Who Achieved mACR 70 Response Score at 6 Months

    Time frame: Baseline, Month 6 (Retrospective data collection from 01 March-2016 to 30-Jun-2022)

    mACR70 response: >= 70% improvement in tender and swollen joint count and 70% improvement 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 j-HAQ (scored from 0 to 3, higher scores indicated worsening of function).

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 39066962Tanaka Y, Kishimoto M, Sonomoto K, Amano K, Harigai M, Onofrei A, O'Brien J, Margolin Z, Barr C, Mizuno Y, Agarwal E, Sugiyama N, Yamanaka H. Methotrexate, Tofacitinib, and Biologic Disease-Modifying Antirheumatic Drug Safety and Effectiveness Among Patients with Rheumatoid Arthritis in Japan: CorEvitas Registry Observational Study. Rheumatol Ther. 2024 Oct;11(5):1237-1253. doi: 10.1007/s40744-024-00700-2. Epub 2024 Jul 27.
• 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.

1 site in 1 country: see every site and its status.