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

Study acronym: ALDORA
StatusRecruiting
PhasePhase 3
Started2022-06-22
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 12, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-03-10
Study Identification, Study Status, Oversight, IPDSharing v3
Primary completion date2024-03→2026-03
Completion date2024-03→2026-03
Study titlerevised
Evaluation of Spironolactone Efficacy in Patient Withwith Rheumatoid Arthritis (RA)
2022-12-06
Study Status, Eligibility v2
Eligibility criteria-18 characters
[...] nt 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 s [...] ailure, cirrhosis hypersensitivity to the active ingredients, to sulfonamides or intolerance to any of the excipients including lactose A [...] ne treatment in the last 3 months concomitant treatment with: mitotane, other potassium-sparing diuretics (alone or in com [...]
2022-08-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-08→2024-03
Completion date2023-08→2024-03
Start dateestimated 2021-12→confirmed 2022-06-22
Study sites0→1
2021-10-12
Original filing
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)
Trial Details
NCT Number NCT05092984
Lead Sponsor University Hospital, Strasbourg, France
Conditions Rheumatoid Arthritis
Enrollment 154 participants
Start Date 2022-06-22
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-03-12