Stopped: The study is being closed early due to insufficient participant enrollment across study sites.
United States2 participantsStarted 2023-07-25
Plain-language summary
The primary objective is to determine if the addition of a 12-week course of treatment with VIB4920 to TNFi treatment will result in improved clinical disease control in patients with RA who have had an inadequate response to a TNFi.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant or legally authorized representative must be able to understand and provide informed consent
✓. Adults ≥ 18 years of age
✓. Diagnosed with RA by fulfilling the ACR/EULAR 2010 Classification Criteria for RA ≥ 6 months prior to screening (Appendix 9)
✓. Documented positive test for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (ACPA)
✓. SDAI ≥ 17
✓. At least 4 tender and 4 swollen joints by a 44 joint count (Appendix 5)
✓. Receiving treatment with an FDA-approved TNFi (including biosimilars) that is dosed subcutaneously at an FDA-approved dosing regimen for at least 12 weeks.
✓. Willing to continue or discontinue treatment with their current TNFi at the same dose depending upon study arm assignment
Exclusion criteria
✕. Inability or unwillingness to give written informed consent or comply with the study protocol
✕. Prior or ongoing systemic inflammatory or autoimmune disease (other than RA and secondary Sjögren's syndrome) requiring or potentially requiring other systemic immunomodulatory therapy during the 40-week study period
✕. Use of glucocorticoid and/or disease-modifying therapies as specified below:
✕
What they're measuring
1
Proportion of participants achieving low disease activity by Simplified Disease Activity Index (SDAI)
Timeframe: Week 16
Trial details
NCT IDNCT05306353
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)