STUDY OF CLINICAL EVOLUTION, IRM AND SYNOVITIS AND CHANGES IN GENE EXPRESSION PROFILES IN RESPONSE TO SARILUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS WHO DO NOT RESPOND TO BIOLOGICAL AGENTS BLOCKING TNF

Phase 1

• Conditions: Medical condition – Rheumatoid Arthritis; MedDRA version: 21.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-003138-17-BE
• Lead Sponsor: Cliniques universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-05
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified