RecruitingPhase 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

Pakistan120 participantsStarted 2025-12-06

Plain-language summary

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.

Who can participate

Age range50 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Major Adverse Cardiovascular Event

Timeframe: 6 months

Compare Incidence of MACE in two group

Timeframe: 6 months

Trial details

NCT IDNCT07554820

SponsorShaikh Zayed Hospital, Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Masooma Hashmat, FCPS Rheumatology

+923353053304 masoomahashmat@gmail.com

View on ClinicalTrials.gov More Rheumatoid Arthritis trials