2024-514201-61-00RecruitingPhase 4
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Jan 2026
Brief summary (registry, in English)
To study the global gene expression profiles, as well as pathological and immunohistochemical characteristics of synovial biopsies obtained in these RA patients
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 18 Jul 2024
- Start date
- 10 Dec 2019
- Lead sponsor
- Cliniques Universitaires Saint-Luc
- Diseases
- Rheumatoid arthritis
- EU CT number
- 2024-514201-61-00
- EudraCT number
- 2019-003138-17
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active rheumatoid arthritis who still have symptoms despite treatment with a TNF biologic medicine plus methotrexate.
- Age
- At least 18 years old.
- Sex
- Men and women can join.
- Disease stage
- Rheumatoid arthritis meeting the 2010 EULAR/ACR criteria, with more than 4 tender joints, more than 4 swollen joints out of 68, and a DAS28-CRP above 3.7.
- Earlier treatment
- Must have been treated with a TNF BioDMARD for 3 months on a stable dose of MTX. Must not have had other biologic or JAK inhibitor drugs (Abatacept, Tocilizumab, Rituximab, JAK inhibitor).
Main reasons for not taking part
- Pregnant or breastfeeding women, or women of child-bearing age not using effective contraception
- Cancer within the last five years (except non-melanoma skin cancers removed by local surgery)
- Serious bacterial infection or risk for tuberculosis
- Unable to accept and carry out the study procedure
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.