Effectiveness and safety of de-escalation of methotrexate and/or baricitinib after achieving remission in patients with rheumatoid arthritis RA-BE-LEAVE study - RA-BE-LEAVE study

Miyazaki Yusuke0 个研究点目标入组 210 人开始时间: 2023年2月13日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Patients aged over 18 years (at the time of informed consent)
•2) Patients diagnosed with rheumatoid arthritis (RA) under the 2010 American College of Rheumatology (ACR) or 2010 European League Against Rheumatism (EULAR) criteria
•3) Patients who have been receiving combination therapy with BARI 4mg and MTX(6-16 mg/week) for more than 6 months before enrollment of the study
•4) Patients who have been showing SDAI 3.3 or less for over 3 months before enrollment
•5) Patients who agree to stop taking adrenocortical hormone and/or who is not taking adrenocortical hormone at the time of screening
•6) Patients who provided written informed consent

•1)Patients whose physician predicts that they have risks of the appearance or worsening of renal dysfunction, blood cell loss, or infection if they continue on BARI 4 mg + MTX treatment.
•2)Patients who have undergone surgical procedures for rheumatoid arthritis within 8 weeks prior to enrollment or who has a plan during the study period.
•3)Patients with at least two episodes of venous thrombosis (deep vein thrombosis/pulmonary thromboembolism) prior to enrollment.
•4)Patients with contraindications of BARI and MTX in the attached documents or clinically.
•5)Female patients who are pregnant or lactating.
•6)Patients with novel coronavirus or who have not yet 2 weeks past after healing from novel coronavirus.
•7) Patients with comorbidities that may affect the evaluation.

发起方

Miyazaki Yusuke