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

Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA) (NCT05092984) is a Phase 3 interventional studying Rheumatoid Arthritis, sponsored by University Hospital, Strasbourg, France. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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)

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Rheumatoid Arthritis, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 154 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Rheumatoid Arthritis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DRUG

Spironolactone

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.

DRUG

Placebo

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Hospital, Strasbourg, France

Strasbourg, Alsace, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05092984), the sponsor (University Hospital, Strasbourg, France), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05092984 clinical trial studying?

Who can participate in NCT05092984?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05092984?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05092984. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05092984. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.