RecruitingPhase 2NCT06640309

The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients

Sponsor

Ain Shams University

Enrollment

70 participants

Start Date

Dec 2, 2023

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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 Criteria8

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.