Actively Recruiting
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
Led by Shaikh Zayed Hospital, Lahore · Updated on 2026-04-28
120
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Rheumatoid arthritis diagnosis with moderate to severe disease activity based on DAS-28 despite treatment with more than 2 conventional DMARDs
- Presence of one or more cardiovascular disease risk factors such as hypertension, diabetes, smoking, or high cholesterol
- Age 50 years or older
You will not qualify if you...
- Known contraindications to statin medications
- History of major adverse cardiovascular events such as recent myocardial infarction or stroke
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shaikh Zayed Hospital, Lahore
Lahore, Punjab Province, Pakistan, 45000
Actively Recruiting
Research Team
M
Masooma Hashmat, FCPS Rheumatology
CONTACT
A
Aflak Rasheed, FCPS Rheumatology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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