RecruitingPhase 3NCT05092984

Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)

Sponsor

University Hospital, Strasbourg, France

Enrollment

154 participants

Start Date

Jun 22, 2022

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

Summary

Evaluation of spironolactone, a well-known cardiological treatment, in patients with rheumatoid arthritis (RA). The hypothesis is that spironolactone, through its anti-inflammatory and anti-fibrosis actions, decreases RA's activity. The primary objective is to assess the efficacy of spironolactone on RA activity by evaluating the proportion of patients achieving DAS28-CRP \< 3.2 at 3 months (comparison between spironolactone and placebo arms). CRP (C reactive protein)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether spironolactone — a medication commonly used for heart conditions and fluid retention — can also help reduce symptoms and inflammation in people with rheumatoid arthritis (RA) that has not responded well to their current treatment. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis according to standard criteria - Your RA is currently active (disease activity score above 3.2) - You have been on a stable dose of RA medication for at least 12 weeks and it is not fully working - You are 18 or older and have signed the informed consent - If you are a woman of childbearing age, you agree to use effective contraception during the study **You may NOT be eligible if...** - Your RA is well-controlled on current medication - You have kidney problems that make spironolactone unsafe - You are already taking medications that interact with spironolactone - You are pregnant, breastfeeding, or planning to become pregnant - You have hyperkalemia (high blood potassium levels) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSpironolactone

77 patients will be treated with spironolactone Mylan 25mg/day for the first 3 months of the study. Dosage adjustment can be performed according to the eGFR (estimated Glomerular Filtration Rate) concentration at baseline and the serum potassium variation. During the last 3 months of the study, all the patients will be treated with spironolactone Mylan 25mg. Dosage adjustment can be performed according to the serum potassium variation.

DRUGPlacebo

77 patients will be treated with placebo 25mg/day for the first 3 months. At inclusion, a second randomization is automatically performed in the placebo arm to determine patients receiving a dose adjustment during the study to keep the double-blind. During the last 3 months of the study, all the patients will be treated with spironolactone Mylan 25mg. Dosage adjustment can be performed according to the serum potassium variation.