Study of clinical response, MRI progression, synovitis and changes in gene expression profiles in response to Sarilumab in patients with rheumatoid arthritis not responding to ANTI-TNF therapy
Key facts
- Where
- Sint-Lambrechts-Woluwe, BelgiumSee the site
- Phase
- 4. fázis
Where in Belgium
- Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cliniques Universitaires Saint-Luc
- Trial code
- EU 2024-514201-61-00
- Record updated
- 2026. január 23.
- Original description
To study the global gene expression profiles, as well as pathological and immunohistochemical characteristics of synovial biopsies obtained in these RA patientsRead full original descriptionShow less
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
To study the global gene expression profiles, as well as pathological and immunohistochemical characteristics of synovial biopsies obtained in these RA patients
Inclusion: 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; Subjects must meet the criteria of the 2010 EULAR/ACR criteria for the diagnosis of rheumatoid arthritis; 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; Subjects must be treated with a TNF BioDMARD since 3 months on a background stable dose of MTX; Subjects must be naive to non TNF BioDMARDs (Abatacept, Tocilizumab, Rituximab and JAK inhibitor).
Exclusion: 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; Subjects with any serious bacterial infection and at risk for tuberculosis (TB); WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy or women who are pregnant or breastfeeding; Subjects unable to accept and perform the procedure.