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 - P1200_51

Cliniques Universitaires Saint-Luc0 sites30 target enrollmentStarted: July 18, 2024Last updated: August 21, 2024

Conditions

Trial Snapshot

No summary available.

•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 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, 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)

•1)WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy or women who are pregnant or breastfeeding, 2)Subjects with a history of cancer within the last five years (other than nonmelanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing., 3)Subjects with any serious bacterial infection and at risk for tuberculosis (TB)., 4)Subjects unable to accept and perform the procedure.

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