arthritis rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Synovial gene transcripts associated with non-response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biomarkers associated with non-response and with molecular and immunological pathways in synovial tissue. | — |
Countries
Netherlands
Outcome results
None listed