Phase 3 Rheumatoid Arthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People who have been diagnosed with rheumatoid arthritis (RA) according to standard 2010 classification guidelines
• People whose RA is currently active, based on a disease activity score called DAS28-CRP being 3.2 or higher
• People who have not responded well enough to their current arthritis medication (cDMARD, tsDMARD, or bDMARD) taken at a stable dose for at least 12 weeks
• People who have been on a stable dose of corticosteroids (steroid tablets) for at least 4 weeks before joining
• People who are able to understand the aims and risks of the study and are willing to sign a dated consent form before any study procedures begin
• People who have been told the results of their initial medical check-up before joining
• Women who could become pregnant must have no plans to become pregnant during the study and must agree to use an accepted contraception method throughout the study and until 5 days after their last visit or last dose; accepted methods include progestogen-only oral contraceptives (where ovulation suppression is not the main action), male or female condoms with or without spermicide, or a cap, diaphragm, or sponge used with spermicide (confirm with trial site for full details)
• People who are enrolled in a social security scheme (this appears to be a French healthcare system requirement — confirm with trial site)

Who may not be able to join:

• People with severe or acute kidney problems, defined as an eGFR below 30 mL/min
• People with high potassium levels in their blood (above 5.1 mmol/L)
• People with end-stage liver failure or cirrhosis
• People with a known allergy or sensitivity to the active ingredients or any components of the study medication, including lactose
• People with a condition called Addison's disease (a disorder affecting the adrenal glands)
• People currently taking spironolactone, or who have taken it within the last 3 months
• People currently taking certain other medications, including mitotane, or potassium-sparing diuretics such as amiloride, potassium canrenoate, eplerenone, or triamterene
• People who have another type of inflammatory joint condition, except for associated Sjögren's syndrome
• Women who are pregnant (confirmed by a blood test at the first study visit)
• Women who are breastfeeding
• People who have taken part in another clinical trial using an investigational (experimental) product within the 4 weeks before this study starts, or who are still within an exclusion period from a previous trial
• People who are unwilling or unable to follow the study requirements, for example due to language barriers or cognitive difficulties
• People who are detained by law for psychiatric or other medical reasons
• People who cannot commit to being followed up for 6 months
• Adults who are under legal protection orders or who are deprived of their liberty by a court or administrative decision

Important: Always verify eligibility with the trial site directly before applying.