Evaluating spironolactone for treating rheumatoid arthritis
Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
This study is testing if the heart medication spironolactone can help people with rheumatoid arthritis feel better by reducing their disease activity.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg, Alsace) |
| Trial ID | NCT05092984 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of spironolactone, a medication typically used for cardiovascular conditions, in patients with rheumatoid arthritis (RA). The study aims to determine if spironolactone can reduce RA activity by measuring the proportion of patients achieving a specific disease activity score (DAS28-CRP) after three months of treatment. Participants will be randomly assigned to receive either spironolactone or a placebo, with the hypothesis that spironolactone's anti-inflammatory and anti-fibrotic properties will lead to improved outcomes in RA management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with a confirmed diagnosis of rheumatoid arthritis and active disease despite stable treatment with disease-modifying antirheumatic drugs (DMARDs).
Not a fit: Patients who are not experiencing active rheumatoid arthritis or those who have not had an insufficient response to DMARDs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with rheumatoid arthritis, potentially improving their disease management and quality of life.
How similar studies have performed: Previous open-label trials have suggested that spironolactone may be effective in treating rheumatoid arthritis, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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 Criteria:
* severe or acute renal insufficiency, defined by eGFR \< 30 mL/min
* hyperkalemia, with K+ \> 5,1 mmol/L
* end-stage liver failure, cirrhosis
* hypersensitivity to the active ingredients or intolerance to any of the excipients including lactose
* Addison's disease
* patient currently being treated with spironolactone, or previous spironolactone treatment in the last 3 months
* concomitant treatment with:
* mitotane,
* other potassium-sparing diuretics (alone or in combination) such as amiloride, potassium canrenoate, eplerenone, triamterene
* other inflammatory arthritis except associated Sjögren's syndrome
* pregnancy (women of childbearing potential : positive blood pregnancy test at the inclusion visit (V0))
* breastfeeding
* 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
* 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.
* patient who cannot be followed for 6 months
* patient over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision (vulnerable subjects)
Where this trial is running
Strasbourg, Alsace
- University Hospital, Strasbourg, France — Strasbourg, Alsace, France (Recruiting)
Study contacts
- Principal investigator: Jacques-Eric GOTTENBERG, MD, PhD — University Hospital, Strasbourg, France
- Study coordinator: Jacques-Eric GOTTENBERG, Professor
- Email: jacques-eric.gottenberg@chru-strasbourg.fr
- Phone: 3 88 12 79 53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.