A Phase 2/3 interventional study of Nicorandil Oral Tablet and Placebo in Rheumatoid Arthritis (RA), sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment
The aim of this clinical trial is to determine whether nicorandil works in minimizing disease severity in patients with rheumatoid arthritis. The study will also assess the safety and tolerability of nicorandil. The main questions it aims to answer are:
Participants will:
Rheumatoid arthritis (RA) is a progressive systemic inflammatory autoimmune disease mainly affecting joints. Adequate treatment and control are important to prevent disease progression and extra-articular complications. Nicorandil is a nicotinamide anti-anginal drug with a potent anti-ischemic, anti-hypoxic, anti-inflammatory and immunomodulatory characteristics that may be potentially effective in the management of autoimmune diseases. Therefore, nicorandil would be a candidate intervention based on previous clinical trial on non-RA patients and animal studies on RA models.
This randomized stratified double-blinded clinical trial will recruit 70 patients based on inclusion criteria. Patients will be randomized to either receive nicorandil 10 mg twice daily or placebo twice daily in addition to conventional treatment for RA for 3 months. The study will be carried out according to ethical considerations.
Patients will be evaluated on monthly bases. At baseline patient history, demographic data, medical and medication history will be documented through patient interview and medical records. At baseline and after completion of 3 months of treatment, investigator will evaluate the patient for treatment safety and efficacy. Evaluation will include disease activity, frequency for using analgesics, quality of life, level of inflammatory mediators, and cartilage integrity. Throughout the study, patient will be followed up closely for any reported adverse effect. At the end of the study, statistical analysis will be done using SPSS software package and the appropriate test will be used.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 70 is below the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive the standard of conventional treatment (cDMARDs with/without corticosteroids) in addition to nicorandil 10 mg tablets twice daily for 3 months (12 weeks).
Drug: Nicorandil Oral Tablet · Drug: conventional synthetic antirheumatic drugs (cDMARDs)
Patients will receive the standard of conventional treatment (cDMARDs with/without corticosteroids) in addition to placebo tablets twice daily for 3 months (12 weeks).
Drug: Placebo · Drug: conventional synthetic antirheumatic drugs (cDMARDs)
Nicorandil 10 mg oral tablets will be taken as one tablet twice daily for 3 months (12 weeks).
Also known as: Randil
Placebo oral tablets will be taken as one tablet twice daily for 3 months (12 weeks).
A single or combination of cDMARDs and dose depend on disease severity.
Also known as: methotrexate, leflunomide, sulfasalazine, hydroxychloroquine
Evaluation of treatment Efficacy
Treatment efficacy will be evaluated using disease activity score DAS-28 (ESR) and the frequency of using analgesics due to arthritis pain. Erythrocyte sedimentation rate (ESR) (mm/hr) will be measured using the Westergren method. Score interpretation: Score \<2.6 means disease remission, 2.6-3.2 means low disease activity, \>3.2-5.1 means moderate disease activity, and \>5.1 means high disease activity. After treatment intervention, a DAS-28 score reduction by 0.6 represents a moderate improvement, while a reduction more than 1.2 represents a major improvement. The frequency of using analgesics will be documented by patient using a diary sheet and weekly evaluation.
Time frame: At baseline and at the end of the study (3 months (12 weeks)).
Evaluation of quality of life (QOL)
Patients՚ QOL will be evaluated using the validated Arabic version of the Health Assessment Questionnaire Disability Index (HAQ-DI). The questionnaire involves eight different aspects evaluating patients' daily activities. Each aspect consists of 2 to 3 questions that are scored from 0 (without any difficulty) to 3 (unable to do). The higher the score, the poorer the QOL.
Time frame: At baseline and at the end of the study (3 months (12 weeks)).
Evaluation of inflammation
Blood samples will be collected from patients at baseline and at the end of the study after 3 months. Blood samples will be directly centrifuged and serum will be stored at -80 °C until analysis. Inflammation will be evaluated through measuring the serum level of C reactive protein (CRP) (mg/L) using the Nephelometric method.
Time frame: At baseline and at the end of the study (3 months (12 weeks)).
Nicorandil safety assessment
All patients will be educated on how to use nicorandil and the most probable adverse effects. They will be evaluated for adverse effects and their severity on monthly visits. Patients will be informed to report any adverse effects and their severity to the investigator by phone calls and at the time of the clinical visit. The most commonly associated adverse effects include headache, GIT, skin or mucosal ulceration, decreased appetite, and orthostatic hypotension. As a preventive measure, blood pressure will be measured at baseline and periodically to exclude patients with significant hypotension.
Time frame: Monthly for 3 months (12 weeks).
Plan to share: No — Sharing IPD may increase risk for patient re-identification, and data secondary analysis misinterpretation.
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Studies of the drug tested here: Nicorandil