eligibility_summary
Eligible: adults 18–80, BSA 1.5–2.2 m2, RA ≥6 mo (2010 ACR/EULAR) with active disease (≥6 swollen and ≥6 tender joints, DAS28 ≥3.2), TNF‑inhibitor–naïve, on stable MTX 7.5–25 mg/wk ≥12 wks, contraception, women not pregnant/lactating. Exclude: other autoimmune/arthritides, class IV RA, HBV/HCV/HIV/COVID/TB, major comorbidities, cancer <5y, hematologic/immune disorders, prior biologics/B‑cell/TNF, >10 mg steroids, abnormal labs, surgery/vaccines/trials, opioid use, substance abuse, no venous access, blood loss >500 mL.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT04680962 (withdrawn pre‑recruitment) compared MabionCD20 (a candidate rituximab biosimilar) with EU‑approved MabThera and US‑licensed Rituxan in moderate–severe rheumatoid arthritis on background methotrexate. Interventions: all are biological chimeric IgG1 monoclonal antibodies against CD20 (B‑cell depleting agents). Mechanism of action: bind CD20 on B lymphocytes, inducing depletion via antibody‑dependent cellular cytotoxicity, complement‑dependent cytotoxicity, and apoptosis, this reduces autoantibody production and modulates antigen presentation and cytokine signaling. Dosing: 1000 mg IV on Days 1 and 15, optional retreatment at Week 24. Targets: CD20+ B cells (pre‑B to mature, sparing plasma cells), Fcγ receptor and complement pathways, downstream effects include lowering RF/anti‑CCP autoantibodies and dampening B–T cell interactions driving synovial inflammation.