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

Recruiting now · Phase 4

Conditions studied: Rheumatoid Arthritis, Major Adverse Cardiac Events

In brief

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.

Key facts

Study ID

NCT07554820

Run by

Shaikh Zayed Hospital, Lahore

People needed

120

Starts

2025-12-06

Expected to finish

2026-09-30

Last updated by the study team

2026-04-28

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

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

Where it is running

• Shaikh Zayed Hospital, Lahore — Lahore, Punjab Province, Pakistan (enrolling)

Full record on ClinicalTrials.gov

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