Rhumatoid ArthisisPhase 3RANCT07516769
Nicorandil as Anti-inflammatory in Rheumatoid Arthritis
A Phase 3 study testing Nicorandil 5 MG Oral Tablet in people with Rhumatoid Arthisis, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the possible efficacy and safety of nicorandil as anti-inflammatory in managing patients with active rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rhumatoid Arthisis
- What is being tested?
- Nicorandil 5 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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
Tanta university
Tanta, Gharbia Governorate
Karim Abu elfath Hussein, +201141332986, Kareem_hussein@pharm.tanta.edu.eg
About this study
Official title: Clinical Study Evaluating the Effect of Nicorandil as Anti-inflammatory and Immune Modulatory in Patients With Rheumatoid Arthritis
This study aims to evaluate the possible efficacy and safety of nicorandil as anti-inflammatory in managing patients with active rheumatoid arthritis.
- Conditions
- Rhumatoid Arthisis
- Being tested
- Nicorandil 5 MG Oral Tablet
- Keywords
- Rhumatoid Arthisis, Nicorandil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicorandil 5 MG Oral TabletDrug
Nicorandil 5 MG Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | this group will include 23 patients who will receive their traditional therapy of RA for 3 months. |
| Nicorandil group | Active comparator | this group will include 23 patients who will receive 5 mg nicorandil twice daily before meals plus the traditional therapy of RA for 3 months. Receives: Drug: Nicorandil 5 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP)
Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) where: Remission: < 2.6. Low Disease Activity (LDA): ≤ 3.2. Moderate Disease Activity (MDA): 3.2 - 5.1. High Disease Activity (HDA): > 5.1
Measured: 3 months
change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores.
Before and 3 months after the intervention, the validated Arabic Multidimensional Health Assessment Questionnaire (MDHAQ) Physical Function: Assessed through 10 activities, scored 0-3 (without difficulty=0, some=1, much=2, unable=3), with higher scores indicating worse function
Measured: 3 months
Secondary outcomes (3)
The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG) at baseline and after 3 months.
Blood samples will be collected at baseline and after 3 months
Measured: 3 months
The change in the serum level of Interleukin 6 (IL-6) at baseline and after 3 months .
Blood samples will be collected at baseline and after 3 months
Measured: 3 months
The change in the serum level of C- reactive protein (CRP) at baseline and after 3 months.
Blood samples will be collected at baseline and after 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Nov 2024
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhumatoid ArthisisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Abu El Fath Hussein Abd El Hakim, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516769
- Sponsor's protocol ID
- Nicorandil in RA
- Acronym
- RA
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Effect of Nicorandil as Anti-inflammatory and Immune Modulatory in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07516769
- Acronym / sponsor ID
- RA / Nicorandil in RA
- Conditions
- Rhumatoid Arthisis
- Keywords
- Rhumatoid Arthisis, Nicorandil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the possible efficacy and safety of nicorandil as anti-inflammatory in managing patients with active rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –this group will include 23 patients who will receive their traditional therapy of RA for 3 months. |
| Nicorandil group | Active comparator | Drug: Nicorandil 5 MG Oral Tabletthis group will include 23 patients who will receive 5 mg nicorandil twice daily before meals plus the traditional therapy of RA for 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicorandil 5 MG Oral TabletNicorandil 5 MG Oral Tablet | Drug | Nicorandil group |
Primary outcome
change in 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP)
Time frame: 3 months
Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) where: Remission: < 2.6. Low Disease Activity (LDA): ≤ 3.2. Moderate Disease Activity (MDA): 3.2 - 5.1. High Disease Activity (HDA): > 5.1
change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores.
Time frame: 3 months
Before and 3 months after the intervention, the validated Arabic Multidimensional Health Assessment Questionnaire (MDHAQ) Physical Function: Assessed through 10 activities, scored 0-3 (without difficulty=0, some=1, much=2, unable=3), with higher scores indicating worse function
3 secondary outcomes
The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG) at baseline and after 3 months.
Time frame: 3 months
The change in the serum level of Interleukin 6 (IL-6) at baseline and after 3 months .
Time frame: 3 months
The change in the serum level of C- reactive protein (CRP) at baseline and after 3 months.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicorandil 5 MG Oral Tablet in people with Rhumatoid Arthisis, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Abu Elfath Hussein (+201141332986, Kareem_hussein@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.