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NCT07554820RecruitingPhase 4

Major Adverse Cardiovascular Events (MACE) in Rheumatoid Arthritis Patient With Moderate to Severe Disease Activity Treated With Tofacitinib and Statins vs TNF Inhibitors: TOFSTAT CLINICAL TRIAL

Source: ClinicalTrials.gov · Last updated 28 Apr 2026

Brief summary (registry, in English)

The rationale of our study is to observe the incidence of MACE in RA patients treated with tofacitinib along with statins with one or more cardiovascular disease risks. PRIMARY OBJECTIVE * To determine the incidence of MACE in Rheumatoid Arthritis patients with moderate to high disease activity and with one or more cardiovascular disease risks, which are non-responsive to standard conventional DMARDs (cDMARDs) treatment and are prescribed Tofacitinib 5 mg twice daily along with statin 20 mg daily versus TNF Inhibitors. * The study aim to compare MACE in RA patients treated with tofacitinib and statin versus TNF inhibitors.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
120 (estimated)
First submitted
21 Apr 2026
Start date
6 Dec 2025
Primary completion date
31 Aug 2026
Lead sponsor
Shaikh Zayed Hospital, Lahore
NCT number
NCT07554820

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 120
  • From 6 Dec 2025 to the primary completion date, 31 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known contraindications to statins.
    • History of major adverse CV events (e.g., recent myocardial infarction or stroke).
    • Pregnancy or breastfeeding.

Who the study is looking for

  • • RA diagnosis with moderate to severe disease activity, based on DAS-28 despite on \> 2 conventional DMARDs.
    • One or more CVD risk factors, such as hypertension, diabetes, smoking, high cholesterol, etc.
    • Age 50 or older.

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shaikh Zayed Hospital, Lahore
Coordinator of this site? Confirm its status
LahorePakistanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.