RHEUMATOID ARTHRITIS
Conditions
Interventions
Trade Name: Spironolactone Mylan 25 mg comprimé pelliculé sécable
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Hopitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: - severe or acute renal insufficiency, defined by eGFR 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of spironolactone on rheumatoid arthritis activity at 3 months compared to placebo.;Secondary Objective: 1) To assess the safety of spironolactone in patients with RA 2) To assess the impact of spironolactone on cardiac biomarkers in patients with RA 3) To assess the impact of spironolactone on cardiac parameters in patients with RA (optional for the site) 4) To assess the clinical disease activity index (CDAI) 5) To assess the efficacy of spironolactone on RA activity at 6 months 6) To assess the EULAR/ACR 2010 classification and the Boolean remission 7) To assess the change of concomitant treatments 8) To assess the adhesion to the experimental treatment 9) To assess the evolution of the patient reported outcomes ;Primary end point(s): Proportion of patients achieving DAS28-CRP < 3,2, comparison between spironolactone and placebo arms.;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Adverse events / Serious adverse events rate in each arm 2) NT-proBNP level 3) Cardiac parameters : QRS duration (ms); left ventricular end-diastolic volume index (mL/m2), left ventricular ejection fraction (%); left ventricular mass index (g/m2); left atrial volume index (mL/m2); early mitral flow; velocity (E) (m/s); late (atrial) mitral flow velocity (A) (m/s); E/A ratio; E/ early diastolic tissue velocity (e’); tricuspid annular plane systolic excursion 4) CDAI score 5) Proportion of patients achieving DAS28-CRP < 3,2 at 6 months 6) EULAR/ACR 20, 50, 70 2010 classification score and Boolean remission score 7) Concomitant treatment modification 8) Treatment account (treatment boxes and patient diary) 9) RAPID 3 and HAQ scores ;Timepoint(s) of evaluation of this end point: 1) time participation 2) inclusion, 3 and 6 months 3) inclusion and 3 months 4) inclusion,3 and 6 months 5) 6 months 6) 3 and 6 months 7) 3 and 6 months 8) 3 and 6 months 9) inclusion,3 and 6 months | — |
Countries
France, Switzerland
Contacts
Public ContactEric DEMONSANT
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed