eligibility_summary
Inclusion: Active progressive MS (PPMS/SPMS with relapses/MRI activity), EDSS ≤6.0, neuro stable ≥30 days. Exclusion: MRI/contrast contraindications, pregnancy/breastfeeding, MS mimics, need/recent use or intolerance of systemic steroids/IS, immunodeficiency or active/recent/chronic infection incl HBV/HCV/HIV/syphilis/TB, GFR <45, severe mAb allergy, CHF III–IV, PML, malignancy (except certain in‑situ/skin), recent live vaccine/investig. tx, prior/recent B‑cell depleters or prohibited DMTs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Ocrelizumab (RO4964913), a humanized anti-CD20 monoclonal antibody (biologic) given by IV infusion (300 mg x2 at start, then 600 mg every 6 months, total 2 years). Mechanism: binds CD20 on pre-B to mature B cells, causing B-cell depletion via antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and apoptosis, reduces B cell antigen presentation and proinflammatory cytokine signaling. Targets: CD20+ B cells driving MS immune activity, including compartmentalized meningeal B cells linked to leptomeningeal inflammation and LMCE lesions, evaluates B-cell repertoire changes associated with leptomeningeal inflammation. Design: Open-label, Phase 4, parallel cohorts (LMCE-positive and LMCE-negative progressive MS), all receive ocrelizumab. Status: Withdrawn due to geopolitical conflict (Russia–Ukraine).