eligibility_summary
Adults 18–80 with CIDP (EAN/PNS). Group 1: untreated, disability warranting IVIg+rituximab. Group 2: stable IVIg/SCIg (≥4 infusions or ≥3 mo) plus wear-off, failed withdrawal, or dose increase, each with ≥MCID (aINCAT +1, I‑RODS +4, MRC +2, Vigorimeter +8 kPa). Exclusions include: paranodal Ab neuropathy, prior serious IVIg/RTX reactions, active HBV/HCV, other immunosuppression, BMI>35, active malignancy, serious infection/immunocompromise/cardiac disease, pregnancy. Consent required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Rituximab (MabThera) — chimeric anti‑CD20 IgG1 monoclonal antibody, 1000 mg IV at baseline and week 2, then 500 mg at month 6. Newly diagnosed patients also receive short‑term IVIg induction, Ig‑dependent patients have IVIg/SCIg tapered. Mechanisms: Rituximab depletes CD20+ B cells (pre‑B, naïve, memory, spares plasma cells) via ADCC, complement‑dependent cytotoxicity, and apoptosis, reducing pathogenic autoantibody production and B‑cell antigen presentation to induce remission. IVIg (pooled IgG) immunomodulates via Fcγ receptor blockade, anti‑idiotype neutralization, complement inhibition, and cytokine/T‑cell/B‑cell modulation. Targets: CD20+ B‑cell axis, humoral autoimmunity, Fc/complement pathways.