Synovial Tissue characteristics in Rheumatoid Arthritis patients TreAted with their FIrst Tnf-inhibitor

Completed

• Conditions: arthritis; rheumatoid arthritis; 10003816

• Registration Number: NL-OMON47003
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

* Age * 18 years
* Fulfilling 2010 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for RA (Appendix A).
* DAS28 * 3.2
* At least one clinically active wrist or knee or MCP joint
* Start with aTNFi (all currently approved TNFi are allowed* infliximab (3 mg/kg at week 0, 2, 6 and 14), etanercept, adalimumab, golimumab, certolizumab pegol) within 4 weeks from the baseline study visit.
* Having insufficient response to treatment with * 2 conventional DMARDs.
* Current treatment with either methotrexate (*10 mg/week), sulfasalazine (*2000 mg/day), hydroxychloroquine (*200 mg/day), and/or leflunomide (*10 mg/day).
* Naïve to previous biological treatment regimens, including other TNFi, rituximab, abatacept, tocilizumab (and biosimilar equivalents).

Exclusion Criteria

* Treatment with systemic glucocorticoids at a dose above 10 mg/day of prednisone or equivalent within 4 weeks of enrolment.
* Treatment with intra-articular glucocorticoids in a knee or wrist or MCP joint within 3 months of enrolment.
* Any rheumatic disease other than RA (except secondary Sjogren*s syndrome)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Synovial gene transcripts associated with non-response.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Blood biomarkers associated with non-response and with molecular and<br /><br>immunological pathways in synovial tissue.</p><br>