Tests spironolactone, a heart medicine, in adults with rheumatoid arthritis

Trial details

Who runs it

University Hospital, Strasbourg, France

Trial code

NCT05092984EU 2024-516884-10-00

Record updated

12 March 2025

Original description

Evaluation of spironolactone, a well-known cardiological treatment, in patients with rheumatoid arthritis (RA).Read full original descriptionShow less

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

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)

Inclusion: patients 18 years of age and over; diagnosis of RA according to EULAR/ACR 2010 classification criteria; active RA: DAS28-CRP ≥ 3.2; insufficient response despite a stable DMARD treatment (cDMARD/tsDMARD(targeted synthetic DMARD)/bDMARD) ≥ 12 weeks; stable dose of corticosteroids for at least 4 weeks prior to inclusion; patient able to understand the objectives and risks of the study and to provide a written informed consent to participate in the study, dated and signed before initiating any trial-related procedure; patient having been informed about the results of the preliminary medical visit; if woman of childbearing, they should have no desire to procreate for the duration of their participation in the study, agreeing to use an effective contraception method* during the study and until 5 days following the last visit or last dose of treatment in case of early stop; acceptable birth control methods:; progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; male or female condom with or without spermicide*; cap, diaphragm or sponge with spermicide*; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) are also considered acceptable, but not highly effective, birth control methods; affiliation to a social security regime.

Exclusion: patient currently being treated with spironolactone, or previous spironolactone treatment in the last 3 months; participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment or still under the exclusion period; end-stage liver failure, cirrhosis; hypersensitivity to the active ingredients or intolerance to any of the excipients including lactose; Addison's disease; other inflammatory arthritis except associated Sjögren's syndrome; unwillingness or incapacity to adhere to study protocol (language barriers, cognitive disorders, etc.); subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness; severe or acute renal insufficiency, defined by eGFR < 30 mL/min; hyperkalemia, with K+ > 5,1 mmol/L; concomitant treatment with:; mitotane,; other potassium-sparing diuretics (alone or in combination) such as amiloride, potassium canrenoate, eplerenone, triamterene; patient over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision (vulnerable subjects); pregnancy (women of childbearing potential : positive blood pregnancy test at the inclusion visit (V0)); breastfeeding; patient who cannot be followed for 6 months.

ClinicalTrials.gov NCT05092984 · EU CTIS 2024-516884-10-00