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Taking people in BelgiumPhase 4

Testing sarilumab in rheumatoid arthritis patients not helped by anti-TNF drugs

Tests sarilumab in adults with rheumatoid arthritis who did not respond to anti-TNF drugs.

Key facts

Who runs it
Cliniques Universitaires Saint-Luc
Where
Sint-Lambrechts-Woluwe, BelgiumSee the site
Registry title
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
Status
Recruiting
Phase
Phase 4
People taking part
30 people, planned
Started
10 Dec 2019
Expected to end
30 Apr 2027
Type of study
Interventional
Record updated
23 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

Where in Belgium

  • Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumTaking people

About the trial

What the trial wants to find out

To study the global gene expression profiles, as well as pathological and immunohistochemical characteristics of synovial biopsies obtained in these RA patients

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Testing sarilumab in rheumatoid arthritis patients not helped by anti-TNF drugsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
23 January 2026