Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
Recruiting
Phase 3
Interventional Study
Rheumatoid Arthritis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 154 (estimated)
- Sponsor
- University Hospital, Strasbourg, France · Other
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About This Trial
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 (comp…
Trial Locations
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Eligibility 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 corticost…
Contacts