sing adalimumab serum concentration to choose a subsequent biological DMARD in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): a blinded randomized superiority trial

Reade Rheumatology Research Institute0 个研究点目标入组 84 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•Rheumatoid arthritis patient, according to ACR 1987 or ACR/EULAR 2010 criteria;
•Recently failed treatment with adalimumab (defined as DAS28-CRP >2.9) and not treated with a subsequent biological DMARD (bDMARD) or target synthetic DMARD (tsDMARD)
•Who has agreed to participate (written informed consent);
•Received adalimumab for at least 10 weeks in standard dosing (40mg subcutaneously every other week, either in monotherapy or combined with methotrexate or leflunomide);
•Stop adalimumab due to inefficacy, either alone or combined with side effects;
•Age 16 years or older.

•Treatment with another TNF inhibitor prior to adalimumab
•Treatment with all non-TNFi options (abatacept, rituximab, sarilumab and tocilizumab) prior to adalimumab
•Scheduled surgery during the follow-up of the study or other pre-planned reasons for treatment discontinuation
•Life expectancy shorter than follow-up period of the study;
•No possibility to safely receive an TNF-inhibitor or a non TNF-inhibitor

发起方

Reade Rheumatology Research Institute