JAK inhibitor dose TAPering strategy study in low disease activity rheumatoid arthritis patients.

Phase 1

• Conditions: Rheumatoid arthritis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-509788-25-00
• Lead Sponsor: Centre Hospitalier Universitaire De Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

Aged = 18 years., Rheumatoid arthritis defined by the ACR/EULAR criteria., Treated with a JAK inhibitor, full dose for at least 6 months., The JAK inhibitor is prescribed as monotherapy or combined with a csDMARD with a stable dosage for at least 3 months before inclusion., Being in LDA (CDAI=10) for at least 6 months., With a CRP level below the laboratory standard at the inclusion visit., Women of childbearing potential (WCBP) must have a negative pregnancy test before starting study

Exclusion Criteria

Concomitant disease needing to be treated by the JAK inhibitor at full-dose (for example inflammatory bowel disease)., Fibromyalgia, Anticipated poor compliance with the strategy., Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation., Alcohol and/or drug misuse as determined by the investigator., Pregnancy or breastfeeding., Non-affiliation to the French Social Security System., Patient unwilling to sign the informed consent form, Patient under legal protection., Patient with a history of JAK-inhibitor dose reduction/spacing before enrollment in the study with the JAK-inhibitor currently being taken., Evidence of flare-up within the last 6 months., Patient who received glucocorticoids > 5mg/day in the 3 months prior the inclusion because of RA., Patient requiring corticoid joint injections in the 3 months prior to inclusion or with scheduled joint injections, to control disease activity., Patient at risk for complication according to the ANSM (current or past smokers, patients at risk of VTE, cancer or major cardiovascular problems, aged = 65 years) at baseline AND currently taking baricitinib or filgotinib., Patient taking associated bDMARD (including anti-TNF, anti-IL6, anti-CD20, abatacept, anti-IL17, anti-IL12/23, anti-IL23, anti-IL1, anti-BAFF, anti-IL5 pathways)., Patient taking immunotherapy for neoplasia., Surgery scheduled in the next 12 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified