Nicorandil for rheumatoid arthritis: a two-phase study comparing it to placebo
Official title: The Effect of Nicorandil on Disease Activity in Rheumatoid Arthritis Patients
Run by Ain Shams University · NCT07730723 · Data updated 2026-11-12
This trial tests whether nicorandil twice daily for 3 months can reduce rheumatoid arthritis symptoms compared with a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Abbasia) |
| Status | Recruiting |
| Started | September 6, 2026 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT07730723 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with RA (ACR/EULAR 2010 criteria) and DAS-28 > 3.2 who are on stable conventional DMARD therapy for at least 3 months.
✕Probably not a fit
Patients with active comorbidities, recent use of biologic or targeted therapies, or intolerance to nicorandil may not benefit and could be excluded due to safety concerns.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, stratified, double-blind study will enroll adults with moderate to severe rheumatoid arthritis who are on stable conventional therapy. Participants will receive either nicorandil 10 mg twice daily or matched placebo in addition to their standard treatment for 12 weeks, with monthly clinic visits and patient diaries to track symptoms and medication use. Outcomes include disease activity (DAS-28), analgesic use, quality of life, inflammatory markers, and cartilage integrity, along with safety and tolerability assessments. The trial is sponsored by Ain Shams University and conducted at Ain Shams University Hospitals in Cairo, with plans to evaluate safety and efficacy compared with placebo. The study builds on prior data suggesting anti-inflammatory and immunomodulatory effects of nicorandil in other contexts.
Why it matters
Potential benefit: If successful, participants may experience reduced joint symptoms and inflammation, and improved daily functioning.
How similar studies have gone: Previous non-RA trials and animal studies have shown anti-inflammatory and immunomodulatory effects with nicorandil, supporting exploration in RA.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (≥18 years). * Confirmed diagnosis with RA according to ACR/EULAR 2010 criteria. * Moderate to severe disease activity (DAS-28 ˃ 3.2). * Stable on conventional treatment for at least 3 months. * Adequate kidney and liver function. Exclusion Criteria: * Other autoimmune diseases * Poor patient compliance * Malignancy or history of malignancy * Pregnancy or lactation. * Patients receiving bDMARDs or tsDMARDs. * Hypersensitivity to nicorandil. * Left ventricular heart failure or severe hypotension (SBP ˂100 mmHg). * History of cardiogenic shock. * History or active gastric ulcer. * Use of drugs contraindicated with nicorandil (e.g., sildenafil, tadalafil, vardenafil, tricyclic antidepressants, or guanyl cyclase).
Where it's running
-
Ain Shams University Hospitals
Cairo, Abbasia, Egypt Recruiting
Study contacts
- Study coordinator: Sondos S. Saleh, Assistant Lecturer
- Email: sondos.sherif.ismail@pharma.asu.edu.eg
- Phone: +201153495055
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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.