JAK inhibitor dose TAPering strategy study in low disease activity rheumatoid arthritis patients - RC31/23/0373

Centre Hospitalier Universitaire De Toulouse0 个研究点目标入组 308 人开始时间: 2024年3月21日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

•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.

发起方