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

Recruiting now · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT06640309

Run by

Ain Shams University

People needed

70

Starts

2023-12-02

Expected to finish

2025-06-01

Last updated by the study team

2024-10-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Ain Shams University Hospitals — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

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