eligibility_summary
Inclusion: IgM MGUS/WM with anti‑MAG demyelinating neuropathy, disease ≤5 yrs with recent worsening, anti‑MAG ≥10,000 BTU, INCAT ≥1, EFNS/PNS ENMG, no IVIG <3 mo or IS <6 mo, neg β‑HCG, contraception 12 mo post‑RTX. Exclusion: prior RTX, mAb/polaramine/methylpred allergy, other neuropathy causes, WM needing IS, uncontrolled disease/CHF, active/recurrent infection, substance abuse, immunodeficiency, WBC<1500/Plt<75k, glaucoma/retention/psychosis, recent/live vaccines.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: THERAMAG (NCT05136976), randomized, double-blind, placebo-controlled Phase 3 in anti‑MAG neuropathy patients selected as likely responders (shorter disease duration, high anti‑MAG IgM titers). Interventions: rituximab (MabThera), a chimeric anti‑CD20 monoclonal antibody, 1 g IV on days 1 and 15, vs placebo (saline). Premedications (dexchlorpheniramine H1 antihistamine, methylprednisolone glucocorticoid, paracetamol) given to both arms. Mechanism of action: rituximab depletes CD20+ B cells via ADCC, CDC, and apoptosis, lowering clonal IgM production and anti‑MAG autoantibody levels. Cells/pathways targeted: CD20+ pre‑B and mature B cells (and short‑lived plasmablast precursors), reducing humoral autoimmunity, downstream impact on anti‑MAG IgM binding to myelin-associated glycoprotein and complement-mediated demyelination in peripheral nerves.