Major Adverse Cardiovascular Events (MACE) in Rheumatoid Arthritis Patient With Moderate to Sever… (NCT07554820) | Clinical Trial Compass
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 range
50 Years – 85 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing tofacitinib plus a statin against TNF inhibitors for rheumatoid arthritis — given my specific heart health history and disease activity level, which treatment arm would I be assigned to, and how does that fit my personal cardiovascular risk profile?
2Since this is a Phase 4 trial tracking serious heart events like heart attacks and strokes as the main outcome, does my doctor think my baseline cardiovascular risk is something we should be actively managing regardless of whether I join this trial?
3I have moderate to severe RA disease activity, which is the target population here — but is there a standard-of-care treatment path my doctor would recommend first before considering participation in a trial that involves monitoring for major cardiac events?
4Tofacitinib is a JAK inhibitor that has had prior safety scrutiny around cardiovascular risks — how does my doctor weigh that existing data when deciding whether this trial or a TNF inhibitor approach makes more sense for me personally?
5What would my follow-up schedule and monitoring look like if I were to discuss joining this trial with my care team, and are there logistical demands — like frequent cardiology check-ins or lab work — that I should factor into my decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.