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

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Strasbourg, France
• Treatments: Spironolactone

Criteria

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, to sulfonamides 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)