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

Korábbi kezelés

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

Más betegség

• 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
• 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.

Laborértékek

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

Életkor

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

Egyéb

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

• 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