Nicorandil as Anti-inflammatory in Rheumatoid Arthritis

NCT07516769 | Recruiting Phase 3 DMC

• 1 other identifier: Nicorandil in RA
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Rhumatoid Arthisis; Nicorandil

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 months

Secondary Outcomes (3)

• The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG) at baseline and after 3 months.

  3 months

• The change in the serum level of Interleukin 6 (IL-6) at baseline and after 3 months .

  3 months

• The change in the serum level of C- reactive protein (CRP) at baseline and after 3 months.

  3 months

Study Arms (2)

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 10 mg nicorandil twice daily before meals plus the traditional therapy of RA for 3 months.

Drug: Nicorandil 10 MG Oral Tablet

Interventions

Nicorandil 10 MG Oral Tablet DRUG

Nicorandil 10 MG Oral Tablet

Nicorandil group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university

Tanta, Gharbia Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

Nicorandil; Tablets

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Karim Abu Elfath Hussein

CONTACT

+201141332986; Kareem_hussein@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: demonstrator at clinical pharmacy department, faculty of pharmacy, Tanta University

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: November 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)