A MULTICENTER, PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF SPIRONOLACTONE FOR THE TREATMENT OF ACTIVE RHEUMATOID ARTHRITIS (RA)

Prior treatment

• 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
• patient currently being treated with spironolactone, or previous spironolactone treatment in the last 3 months

Other illness

• 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
• 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

Lab values

• severe or acute renal insufficiency, defined by eGFR < 30mL/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

Age

• patient over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision (vulnerable subjects)

Other

• breastfeeding
• patient who cannot be followed for 6 months
• pregnancy (women of childbearing potential : positive blood pregnancy test at the inclusion visit (V0))

• patients 18 years of age and over
• diagnosis of rheumatoid arthritis (RA) according to EULAR/ACR 2010 classification criteria
• active RA: DAS28-CRP ≥ 3.2
• insufficient response despite a stable DMARD treatment (cDMARD/tsDMARD/bDMARD) ≥ 12 weeks
• stable dose of corticosteroid 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, she should have no desire to procreate for the duration of her 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
• affiliation to a social security regime