STARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR

CHU Toulouse0 个研究点目标入组 122 人开始时间: 2016年6月9日最近更新: 2022年3月21日

试验速览

暂无简介。

•Patients who have fulfilled the 2010 ACR/EULAR criteria for RA for at least 6 months.
•Aged 18 or over.
•Treated with a stable dose of synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARDs) and/or with a biological DMARD (bDMARD) for at least 3 months.
•Who have been treated with oral prednisone or prednisolone for more than 6 months.
•With a stable dose of 5mg/day of prednisone or prednisolone for at least 3 months.
•And in remission or low disease activity as defined by a DAS28 under 3.2 for at least 3 months.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 122
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 122

•Any chronic condition that would need long-term corticoid use (chronic lung diseases, etc.).
•Evidence of a flare within the last 3 months.
•Evidence of an allergy or intolerance to hydrocortisone or prednisone.
•Chronic idiopathic, or autoimmune clinical adrenal insufficiency.
•Any GC joint injection within the last 3 months or scheduled in the next 3 months.
•Any disease with GC contraindication.
•Treatment with sultopride; injection of alive vaccines
•Significant trauma or major surgery within the 3 months prior to the baseline visit.
•Scheduled surgery in the next 12 months.
•Fibromyalgia.
•Foreseeable poor compliance with the strategy.

发起方

CHU Toulouse