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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

NCT07554820

RecruitingPhase 4

Sponsor: Shaikh Zayed Hospital, Lahore

Conditions: Rheumatoid Arthritis, Major Adverse Cardiac Events

Interventions: Tofacitinib 5 MG

Countries: Pakistan

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 overview

Sex: ALL

Age: 50 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Lahore, Punjab Province, Pakistan