Clinical Research Directory

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)