Nicorandil for reducing inflammation in rheumatoid arthritis
Official title: Clinical Study Evaluating the Effect of Nicorandil as Anti-inflammatory and Immune Modulatory in Patients With Rheumatoid Arthritis
Run by Tanta University · NCT07516769 · Data updated 2026-11-12
This trial will test whether taking a 10 mg nicorandil tablet can reduce inflammation and improve symptoms in adults with active rheumatoid arthritis who are already on conventional DMARDs.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 46 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbia Governorate) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | March 2027 |
| Study ends | April 2027 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07516769 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with active rheumatoid arthritis (DAS28 >2.6) who are on conventional DMARDs, not taking biologic DMARDs, not pregnant or lactating, and without significant cardiac, diabetic, renal, or hepatic disease.
✕Probably not a fit
Patients in remission, those currently treated with biologic DMARDs, pregnant or lactating women, and people with excluded comorbidities such as heart disease, diabetes, or severe organ dysfunction are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial adds oral nicorandil 10 mg to standard conventional DMARD therapy in adults with active rheumatoid arthritis (DAS28 >2.6). Key exclusions include significant cardiac disease, diabetes, active infection, severe renal or hepatic dysfunction, current biologic DMARD use, high-dose prednisone (>15 mg/day), and pregnancy or lactation. The single-center study is conducted at Tanta University and includes in-person visits for screening, dosing, disease activity measurements, and safety monitoring. Outcomes will include changes in joint inflammation and disease activity scores as well as adverse event recording.
Why it matters
Potential benefit: If effective, nicorandil could provide an oral, repurposed option to lower inflammation and improve symptoms for patients with active rheumatoid arthritis on conventional DMARDs.
How similar studies have gone: Nicorandil has known vasodilatory effects and some preclinical data suggest anti-inflammatory properties, but clinical evidence in rheumatoid arthritis is limited and this application remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) i.e., 28 joints disease activity score (DAS-28) \>2.6. * Patients receiving the conventional DMARDs Exclusion Criteria: * Patients with heart disease (congestive heart failure, arrhythmia and ischemic heart disease), diabetes, active infection, and other illness except rheumatoid arthritis. * Patients with severe renal and hepatic dysfunction. - Patients receiving biological DMARDs. * Patients receiving oral prednisolone greater than 15mg/day. * Patients with hypersensitivity to study medications. * Patients using antioxidants. * Pregnant and lactating females.
Where it's running
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Tanta university
Tanta, Gharbia Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Karim Abu Elfath Hussein
- Email: Kareem_hussein@pharm.tanta.edu.eg
- Phone: +201141332986
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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.