eligibility_summary
Adults >=18 with RA per 2010 ACR/EULAR >=1 yr, refractory or intolerant: lack of benefit to >=2 bDMARDs (different classes) or 1 bDMARD + 1 tsDMARD after >=12 wks, or intolerance to same. Need SJC/TJC >=6/6, hsCRP >=0.8 mg/dL, ACPA and/or RF+, stable OCS <=10 mg/day. Exclude JIA, PsA, axial SpA/other inflammatory arthritis, systemic RA (vasculitis, pulmonary fibrosis, Feltys), active fibromyalgia, recent investigational drugs, recent cell-depleting/tsDMARD/bDMARD use, or prednisone >10 mg/day.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1b, randomized, placebo-controlled RA study (terminated) testing imvotamab, an intravenously administered IgM bispecific T‑cell–engaging antibody (CD20×CD3). MOA: binds CD20 on B cells and CD3 on T cells to redirect T‑cell cytotoxicity and deplete pathogenic B cells, placebo was 0.9% saline. Target cells/pathways: CD20+ B cells (drivers of autoantibody-mediated RA) and CD3 on T cells, aims to suppress humoral autoimmune pathways via B‑cell depletion. Study stopped due to insufficient B‑cell depletion.