A 24 weeks proof of concept study to evaluate the clinical, MRI and synovial tissue benefit of Sarilumab in active RA patients despite TNF agents - SARABIO

Cliniques universitaires Saint-Luc0 个研究点目标入组 30 人开始时间: 2019年11月5日最近更新: 2024年8月5日

试验速览

暂无简介。

•1)Males or females (not nursing and not pregnant) at least 18 years of age. Women of child-bearing potential are eligible if they are practicing effective contraceptive measures.
•2)Subjects must meet the criteria of the 2010 EULAR/ACR criteria for the diagnosis of
•1.rheumatoid arthritis
•3)Subjects must have a disease activity as defined by a tender joint count of > 4, swollen joint count of > 4 from 68 joints and a DAS28-CRP >3.7.(This value is the cut off level to obtain a reimbursement for biologics in Belgium).
•4)Subjects must be treated with a TNF BioDMARD since 3 months on a background stable dose of MTX
•5)Subjects must be naive to non TNF BioDMARDs (Abatacept, Tocilizumab, Rituximab and JAK inhibitor)
•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 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1)WOCBP who are unwilling or unable to use an acceptable method to avoid
•2.pregnancy or Women who are pregnant or breastfeeding
•1)Subjects with a history of cancer within the last five years (other than nonmelanoma
•3.skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing.
•2)Subjects with any serious bacterial infection and at risk for tuberculosis (TB).
•3)Unable to accept and perform the procedure.

发起方