Heart event risk in people with moderate-to-severe rheumatoid arthritis taking tofacitinib plus a statin versus TNF inhibitors.
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
Run by Shaikh Zayed Hospital, Lahore · NCT07554820 · Data updated 2026-11-12
This will test whether taking tofacitinib with a daily statin changes the rate of major heart problems in people 50 and older with moderate-to-severe rheumatoid arthritis and at least one cardiovascular risk factor.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Shaikh Zayed Hospital, Lahore Academic / other |
| Drugs / interventions | tofacitinib |
| Locations | 1 site (Lahore, Punjab Province) |
| Status | Recruiting |
| Started | December 6, 2025 |
| Main results expected | August 31, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT07554820 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 50 or older with moderate-to-severe rheumatoid arthritis not responding to more than two conventional DMARDs and with one or more cardiovascular risk factors who can attend monthly visits are the intended participants.
✕Probably not a fit
Patients with a history of major adverse cardiovascular events, known contraindications to statins, or who are pregnant or breastfeeding are excluded and unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-randomized phase 4 comparison of tofacitinib (5 mg twice daily) plus atorvastatin 20 mg daily versus standard TNF inhibitor therapy in patients with moderate-to-severe rheumatoid arthritis and one or more cardiovascular risk factors. Eligible patients are age 50 or older, non-responsive to more than two conventional DMARDs, and will undergo baseline DAS-28 and lipid assessments. Participants will be followed monthly for six months with monthly lipid panels, DAS-28 scoring, and active surveillance for major adverse cardiovascular events (MACE). If a participant experiences a CVD event while on tofacitinib, the drug will be stopped and the event documented.
Why it matters
Potential benefit: If successful, the comparison could clarify whether tofacitinib plus a statin carries higher, lower, or similar risk of major heart events compared with TNF inhibitors, helping guide safer treatment choices.
How similar studies have gone: Large randomized data (for example ORAL Surveillance) have raised concerns about higher MACE risk with tofacitinib versus TNF inhibitors, while the specific effect of adding a statin to tofacitinib has not been well studied.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Shaikh Zayed Hospital, Lahore
Lahore, Punjab Province, Pakistan Recruiting
Study contacts
- Principal investigator: Masooma Hashmat, FCPS — Shaikh Zayed Hospital, Lahore
- Study coordinator: Masooma Hashmat, FCPS Rheumatology
- Email: masoomahashmat@gmail.com
- Phone: +923353053304
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.