Rheumatoid Arthritis (RA)Phase 2/3NCT07730723
The Effect of Nicorandil on Rheumatoid Arthritis Patients
A Phase 2/3 study testing Nicorandil Oral Tablet and conventional synthetic antirheumatic drugs (cDMARDs) in people with Rheumatoid Arthritis (RA), run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Nicorandil Oral Tablet and conventional synthetic antirheumatic drugs (cDMARDs)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Sep 2026to Jul 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Other autoimmune diseases
- Poor patient compliance
- Malignancy or history of malignancy
- Pregnancy or lactation.
- Patients receiving bDMARDs or tsDMARDs.
- Hypersensitivity to nicorandil.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo, Abbasia
Sondos S. saleh, Assistant Lecturer, +201153495055, sondos.sherif.ismail@pharma.asu.edu.eg
Marwa A. AL-Asfahani, Lecturer, +201120029192
About this study
Official title: The Effect of Nicorandil on Disease Activity in Rheumatoid Arthritis Patients
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:
- Could nicorandil improve disease severity and symptoms of rheumatoid arthritis?
- Does nicorandil lower the number of times participants need to use pain relieve medications?
- Does the nicorandil improve participants functionality and ability to carry out daily activity?
- Does nicorandil correct disease-associated damage and inflammation?
- What side effects do participants have when taking nicorandil? Researchers will compare nicorandil to a placebo (a look-alike substance that contains no drug) to see if nicorandil works to decrease symptoms and severity of rheumatoid arthritis.
Read more
Participants will:
- Take nicorandil or a placebo two times daily for 3 months
- Visit the clinic once every month for checkups
- Keep a diary of their symptoms and the number of times they use a pain reliever
Read the detailed description
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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Nicorandil Oral Tablet, Placebo, conventional synthetic antirheumatic drugs (cDMARDs)
- Keywords
- Rheumatoid Arthritis (RA), Nicorandil, Inflammation, DAS-28, Disease activity, Autoimmune disease, HAQ-DI, Quality of life
- Medical subject headings
- Arthritis, Rheumatoid, Inflammation, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicorandil Oral TabletDrug
Also called Randil
Nicorandil 10 mg oral tablets will be taken as one tablet twice daily for 3 months (12 weeks).
PlaceboDrug
Placebo oral tablets will be taken as one tablet twice daily for 3 months (12 weeks).
conventional synthetic antirheumatic drugs (cDMARDs)Drug
Also called methotrexate, leflunomide, sulfasalazine, hydroxychloroquine
A single or combination of cDMARDs and dose depend on disease severity.
| Study group | Role | What they receive |
|---|---|---|
| Nicorandil group | Experimental | 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). Receives: Drug: Nicorandil Oral Tablet; Drug: conventional synthetic antirheumatic drugs (cDMARDs) |
| Placebo group | Placebo comparator | Patients will receive the standard of conventional treatment (cDMARDs with/without corticosteroids) in addition to placebo tablets twice daily for 3 months (12 weeks). Receives: Drug: Placebo; Drug: conventional synthetic antirheumatic drugs (cDMARDs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and at the end of the study (3 months (12 weeks)).
Secondary outcomes (1)
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.
Measured: At baseline and at the end of the study (3 months (12 weeks)).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start6 Sep 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sondos Sherif Ismail, Ain Shams University
- Investigators
- Nagwa A. Sabri, Professor, Study director, Prof. of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams UniversityMay A. Shawky, Assoc. Prof., Study director, Assoc. Prof. of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730723
- Sponsor's protocol ID
- 2020110301REC480
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD may increase risk for patient re-identification, and data secondary analysis misinterpretation.
Publications
Okasha AH, Hegab II, Seleem MA, Azzam AR, Ibrahim S, Ghalwash AA, El-Gohary RM. Effects of Fisetin and Nicorandil on adjuvant-induced rheumatoid arthritis in rats: Emerging role of TLR4/NF-kappaB-induced Pyroptosis, Nrf-2/HO-1, and OPG/RANKL pathways. Cytokine. 2025 Mar;187:156876. doi: 10.1016/j.cyto.2025.156876. Epub 2025 Jan 29.
PubMed 39884184Zong Y, Li J, Xu X, Xu X. Effects of nicorandil on systemic inflammation and oxidative stress induced by percutaneous coronary intervention in patients with coronary heart disease. J Int Med Res. 2021 Dec;49(12):3000605211058873. doi: 10.1177/03000605211058873.
PubMed 34871513Xu S, Cao X, Yu Z, He W, Pang Y, Lin W, Chen Z, Guo W, Lu X, Lin C. Nicorandil Inhibits Osteoclast Formation Base on NF-kappaB and p-38 MAPK Signaling Pathways and Relieves Ovariectomy-Induced Bone Loss. Front Pharmacol. 2021 Sep 8;12:726361. doi: 10.3389/fphar.2021.726361. eCollection 2021.
PubMed 34566650Saad MA, El-Sahhar AE, Arab HH, Al-Shorbagy MY. Nicorandil abates arthritic perturbations induced by complete Freund's adjuvant in rats via conquering TLR4-MyD88-TRAF6 signaling pathway. Life Sci. 2019 Feb 1;218:284-291. doi: 10.1016/j.lfs.2019.01.002. Epub 2019 Jan 3.
PubMed 30611783Gaafar AGA, Messiha BAS, Abdelkafy AML. Nicorandil and theophylline can protect experimental rats against complete Freund's adjuvant-induced rheumatoid arthritis through modulation of JAK/STAT/RANKL signaling pathway. Eur J Pharmacol. 2018 Mar 5;822:177-185. doi: 10.1016/j.ejphar.2018.01.009. Epub 2018 Jan 11.
PubMed 29337196Quinonez-Flores CM, Gonzalez-Chavez SA, Pacheco-Tena C. Hypoxia and its implications in rheumatoid arthritis. J Biomed Sci. 2016 Aug 22;23(1):62. doi: 10.1186/s12929-016-0281-0.
PubMed 27549205