BridgeMD
Tests treatment safety and results for Rheumatoid Arthritis
Official title Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
ClinicalTrials.gov ID: NCT05092984
What this study is testing
What is Spironolactone?
Spironolactone is an investigational medicine, being studied as a potential treatment for rheumatoid arthritis.
Also referred to as Spironolactone Mylan 25mg.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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.).
- people 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 people)
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, Alsace, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, Alsace, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.