eligibility_summary
Eligible: SPMS per Lorscheider criteria with progression confirmed ≥3 months (≥1 EDSS step if EDSS≤5.5 or 0.5 if EDSS≥6), including within the leading FS, EDSS ≥4 and pyramidal FS ≥2, baseline EDSS ≥6.5. Exclude: prior SPMS DMTs other than rituximab, relapse within 3 months, rituximab hypersensitivity/contraindication, other neurologic disorders affecting cognition or hand function.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Rituximab (chimeric anti-CD20 IgG1 monoclonal antibody), IV 1 g split into two 500 mg doses 2 weeks apart, then 1 g at 6 months, Comparator: 0.9% saline placebo IV. Mechanism of action: Rituximab binds CD20 on pre-B and mature B lymphocytes and depletes them via complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis. This lowers B-cell antigen presentation and T-cell co-stimulation, autoantibody production, and pro-inflammatory cytokines (e.g., IL-6, TNF), aiming to reduce compartmentalized CNS inflammation in SPMS. Cells/pathways targeted: CD20+ B cells (not plasma cells, enriched effect on memory B cells), B-cell–T-cell interaction pathways, Fc/complement effector pathways, downstream attenuation of MS inflammatory circuits affecting cognition and hand function.