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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

RecruitingPhase 4Ages 50 Years - 85 YearsAllShaikh Zayed Hospital, Lahore
NCT07554820 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Tofacitinib 5 MG
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Where

1 site
Shaikh Zayed Hospital, Lahore
Lahore, Pakistan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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