NCT07554820 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
| NCT ID | NCT07554820 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shaikh Zayed Hospital, Lahore |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-12-06 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-12-06 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Masooma Hashmat, FCPS
PRINCIPAL INVESTIGATOR
Shaikh Zayed Hospital, Lahore
Frequently Asked Questions
Who can join the NCT07554820 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07554820 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07554820 currently recruiting?
Yes, NCT07554820 is actively recruiting participants. Contact the research team at masoomahashmat@gmail.com for enrollment information.
Where is the NCT07554820 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07554820 clinical trial?
NCT07554820 is sponsored by Shaikh Zayed Hospital, Lahore. The principal investigator is Masooma Hashmat, FCPS at Shaikh Zayed Hospital, Lahore. The trial plans to enroll 120 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.