eligibility_summary
Eligibility: RRMS (McDonald 2017) with activity in past 12 mo, age 18–55, EDSS ≤5, brain MRI ≤6 mo, WOCBP on effective contraception (+12 mo), consent, insured. Exclude: progressive MS, recent DMTs (anti‑CD20/mitoxantrone/cladribine/alemtuzumab ≤2 y, fingolimod/natalizumab ≤4 w), steroids or relapse ≤30 d, pregnancy/breastfeeding, other disease, other trial ≤6 mo, MRI/anti‑CD20 contraindications (live vaccine ≤6 w, infection, cancer, HIV/HBV/HCV/TB, cardiac dz, hypersensitivity, grade ≥3 lympho/neutropenia, AST/ALT ≥3×ULN, platelets <100), legal protection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05758831 tests two anti-CD20 monoclonal antibodies in active RRMS: rituximab (chimeric IgG1 mAb, off-label in MS) versus ocrelizumab (humanized IgG1 mAb, approved for RRMS) in a randomized, double-blind non-inferiority design over 2 years. Mechanism of action: both bind CD20 on B cells (from pre‑B to mature stages, not plasma cells) and deplete them via antibody‑dependent cellular cytotoxicity, complement‑dependent cytotoxicity, and apoptosis. Targeted cells/pathways: CD20+ B lymphocytes—especially memory B cells—leading to reduced B‑cell antigen presentation to T cells, diminished proinflammatory cytokine production, and lower autoantibody-mediated activity, thereby suppressing B‑cell–driven adaptive immune pathways central to MS disease activity.