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

RECRUITINGPhase 2Sponsored by Ain Shams University
Actively Recruiting
PhasePhase 2
SponsorAin Shams University
Started2023-12-02
Est. completion2025-06
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
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.

Conditions2

ArthritisRheumatoid Arthritis

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