SARILUMAB for Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- 1)\tMales 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."}
• {"criterion_text":"- 2)\tSubjects must meet the criteria of the 2010 EULAR/ACR criteria for the diagnosis of rheumatoid arthritis"}
• {"criterion_text":"- 3)\tSubjects 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"}
• {"criterion_text":"- 4)\tSubjects must be treated with a TNF BioDMARD since 3 months on a background stable dose of MTX"}
• {"criterion_text":"- 5)\tSubjects must be naive to non TNF BioDMARDs (Abatacept, Tocilizumab, Rituximab and JAK inhibitor)"}

Exclusion criteria

• {"criterion_text":"- 1)\tWOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy or women who are pregnant or breastfeeding"}
• {"criterion_text":"- 2)\tSubjects 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."}
• {"criterion_text":"- 3)\tSubjects with any serious bacterial infection and at risk for tuberculosis (TB)."}
• {"criterion_text":"- 4)\tSubjects unable to accept and perform the procedure."}

Primary endpoints

• {"endpoint_text":"- To study the global gene expression profiles, as well as pathological and immunohistochemical characteristics of synovial biopsies obtained in these RA patients and ACR 20, 50 and EULAR response at week 12","definition_or_measurement_approach":"As stated: assessment of global gene expression profiles and pathological and immunohistochemical characteristics of synovial biopsies; measurement of ACR 20, ACR 50 and EULAR response at week 12."}

Belgium

Earliest CTIS Part Ii Submission Date

29-04-2024

Latest Decision Or Authorization Date

23-01-2026

Processing Time Days

634

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Cliniques Universitaires Saint-Luc

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"Sanofi-Aventis","duties_or_roles":"Monetary support (listed as source of monetary support)","organisation_type":""}