The Effect of Nicorandil on Rheumatoid Arthritis Patients
ConditionRheumatoid Arthritis (RA)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University
About this trial
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.
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Other autoimmune diseases
Poor patient compliance
Malignancy or history of malignancy
Pregnancy or lactation.
Trial design
Design model
Parallel
Treatments tested in this trial
Nicorandil Oral Tablet
DrugNicorandil 10 mg oral tablets will be taken as one tablet twice daily for 3 months (12 weeks).
Placebo
DrugPlacebo oral tablets will be taken as one tablet twice daily for 3 months (12 weeks).
conventional synthetic antirheumatic drugs (cDMARDs)
DrugA single or combination of cDMARDs and dose depend on disease severity.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Nicorandil groupExperimental treatment 2 interventions
Group B: Placebo groupPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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)).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.
Time frame
At baseline and at the end of the study (3 months (12 weeks)).Other outcomes
1
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)).2
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).Sponsors and contacts
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Source ClinicalTrials.gov