RecruitingPhase 4NCT07554820

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

Sponsor

Shaikh Zayed Hospital, Lahore

Enrollment

120 participants

Start Date

Dec 6, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis Major Adverse Cardiac Events

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.

Eligibility

Min Age: 50 YearsMax Age: 85 Years

Inclusion Criteria3

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 Criteria3

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

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Interventions

DRUGTofacitinib 5 MG

* In one group tofacitinib (5 mg twice daily) and statins (atorvastatin 20 mg daily) will be added to the treatment regimen of the patients. * In control group TNF inhibitor will be added to the treatment regimen of the patients as part of standard treatment. * Patients will be followed up monthly for a period of 6 months. * Monthly assessments during follow up will include Lipid profile Total cholesterol, LDL, HDL, triglycerides. DAS-28 score. Recording of any CVD events (MACE). Monitoring of any other related complications.