Actively Recruiting
Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
Led by University Hospital, Strasbourg, France · Updated on 2025-03-12
154
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age and older
- Diagnosis of rheumatoid arthritis according to EULAR/ACR 2010 classification criteria
- Active rheumatoid arthritis with DAS28-CRP score of 3.2 or higher
- Insufficient response despite stable DMARD treatment (cDMARD, tsDMARD, or bDMARD) for at least 12 weeks
- Stable corticosteroid dose for at least 4 weeks before inclusion
- Ability to understand study objectives and risks and provide written informed consent
- Informed about results of preliminary medical visit
- Women of childbearing potential must agree to use effective contraception during the study and for 5 days after last dose, with acceptable birth control methods including progestogen-only oral contraception, male or female condoms with or without spermicide, cap, diaphragm, sponge with spermicide, or double barrier methods
- Affiliation to a social security regime
You will not qualify if you...
- Severe or acute kidney failure with estimated glomerular filtration rate (eGFR) below 30 mL/min
- High potassium levels (hyperkalemia) with potassium above 5.1 mmol/L
- End-stage liver failure or cirrhosis
- Allergy or intolerance to spironolactone or any excipients including lactose
- Addison's disease
- Current or recent (within 3 months) treatment with spironolactone
- Concomitant use of mitotane or other potassium-sparing diuretics such as amiloride, potassium canrenoate, eplerenone, or triamterene
- Other inflammatory arthritis except associated Sjögren's syndrome
- Pregnancy or positive pregnancy test at inclusion
- Breastfeeding
- Participation in another clinical trial with an investigational product within the last 4 weeks
- Inability or unwillingness to follow study protocol due to language barriers, cognitive disorders, etc.
- Being compulsorily detained for psychiatric or physical illness
- Inability to be followed for 6 months
- Being legally protected or deprived of liberty by judicial or administrative decisions (vulnerable subjects)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital, Strasbourg, France
Strasbourg, Alsace, France, 67000
Actively Recruiting
Research Team
J
Jacques-Eric GOTTENBERG, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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