eligibility_summary
Eligible: adults 18-65, 50-120 kg, RA >=6 mo (ACR/EULAR 2019) with moderate-severe activity (>=6 tender and >=6 swollen joints plus CRP >=10 mg/L or ESR >=28), anti-CCP >=10 and/or RF >=20, inadequate response/intolerance to >=1 anti-TNF, on MTX >=12 wks (stable 10-25 mg/wk). Exclude: MabThera contraindications, other rheumatic disease, HIV/HBV/HCV, prior rituximab/anti-CD20, pregnancy/lactation, recent COVID/infection, severe allergy to mAbs/rituximab, active TB, significant heart disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Randomized, double-blind Phase I PK/PD equivalence study in RA comparing a Mabscale rituximab biosimilar to MabThera, both with methotrexate + folic acid. Drugs/interventions and mechanisms: • Rituximab/MabThera: chimeric type I IgG1 monoclonal antibody (biologic) targeting CD20 on B cells. Mechanisms: depletes CD20+ pre‑B and mature B cells via ADCC, CDC, and apoptosis, reducing autoantibody production (RF/ACPA), antigen presentation, and B‑cell cytokines. • Methotrexate: conventional synthetic DMARD (antifolate) inhibiting DHFR and AICAR pathways, increasing adenosine, suppressing lymphocyte proliferation and proinflammatory cytokines (e.g., TNF‑α, IL‑6). • Folic acid: vitamin to mitigate MTX toxicity. Cells/pathways targeted: CD20+ B cells, downstream modulation of T‑cell activation, macrophages, and inflammatory cytokine networks in synovium.