Nicorandil as Anti-inflammatory in Rheumatoid Arthritis (RA)

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.

Study Overview

• Status: Recruiting
• Conditions: Rhumatoid Arthisis
• Intervention / Treatment: Drug: Nicorandil 10 MG Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Karim Abu elfath Hussein; Phone Number: +201141332986; Email: Kareem_hussein@pharm.tanta.edu.eg

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt
      • Recruiting
      • Tanta University
      • Contact: Karim Abu elfath Hussein; Phone Number: +201141332986; Email: Kareem_hussein@pharm.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; this group will include 23 patients who will receive their traditional therapy of RA for 3 months.
Active Comparator: Nicorandil group; 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; Nicorandil 10 MG Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Nicorandil; Rhumatoid Arthisis
• Additional Relevant MeSH Terms: Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Dosage Forms; Acids, Heterocyclic; Niacinamide; Nicotinic Acids; Nitrates; Nicorandil; Tablets
• Other Study ID Numbers: Nicorandil in RA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No