The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients
Recruiting · NCT06640309 · Interventional (participants receive a specific treatment) · Lead sponsor: Ain Shams University
View the official record on ClinicalTrials.gov →Interventions studied
Nicotinamide Tabletconventional synthetic antirheumatic drugs
What this trial is about
A randomized controlled interventional study to evaluate the efficacy and safety of nicotinamide supplementation in rheumatoid arthritis patients receiving conventional synthetic disease modifying anti-rheumatic drugs.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Adult patients (18-65 years).
- Patients with a diagnosis of established rheumatoid arthritis.
- Patients presenting with moderate to high disease activity identified as disease activity score-28 based on C-reactive protein levels (DAS-28-CRP) \>3.2.
- Receiving stable regimen of one or more conventional disease modifying antirheumatic drugs for at least the past three months.
- Patients willing to sign an informed consent.
Exclusion criteria
- Patients with a known history of hypersensitivity or drug allergies to nicotinamide
- Patients receiving nicotinamide for any other indications.
- Receiving any dosage forms/ dosage regimen of vitamin B3 supplementation
- Receiving biologic disease modified antirheumatic drugs therapy.
- Impaired liver functions (liver transaminases level ≥ three times upper normal limits).
- Impaired kidney functions (estimated glomerular filtration rate (eGFR) \< 30 ml/min)
- Pregnancy and lactation.
- Patients with other auto-immune diseases.
Where it is running
1 location listed.
- Ain Shams University Hospitals - Cairo, Egypt