Nicorandil as Anti-inflammatory in Rheumatoid Arthritis (NCT07516769) | Clinical Trial Compass
RecruitingPhase 3
Nicorandil as Anti-inflammatory in Rheumatoid Arthritis
Egypt46 participantsStarted 2024-11-01
Plain-language summary
This study aims to evaluate the possible efficacy and safety of nicorandil as anti-inflammatory in managing patients with active rheumatoid arthritis.
Who can participate
Age range
18 Years – 70 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:
* 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.
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.
1Nicorandil is typically used for heart conditions — since this Phase 3 trial is testing it as an anti-inflammatory for rheumatoid arthritis, what do we currently know about its safety profile when used by people with RA who may not have heart problems?
2This trial measures disease activity using the DAS28-CRP score and a patient self-report questionnaire called the MDHAQ — based on where my own disease activity sits right now, would my numbers actually be meaningful to track in a study like this?
3Since this is a Phase 3 trial, it's further along in the research process — does that mean there's already some evidence that nicorandil reduces inflammation in RA, and if so, how does that compare to the treatments I'm currently on or being considered for?
4Would joining this trial mean changing or stopping any of my existing RA medications, and if my condition worsens during the study, what are the options for switching back to standard care?
5Are there other standard-of-care options or approved biologics we haven't tried yet that might be worth exploring before considering an investigational add-on like nicorandil?
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.
What they're measuring
1
change in 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP)
Timeframe: 3 months
2
change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores.