eligibility_summary
MS (2017 McDonald), EDSS ≤6.5. Active RRMS (past 12 mo): naïve with 2 relapses, or 1 relapse + severe residual & EDSS ≥3.0, or 1 relapse + ≥9 T2 and new/CE MRI, pre‑treated: 1 relapse or MRI activity (CE or ≥2 new/enlarging T2). Exclude: pregnancy/breastfeeding, no effective contraception, recent live vaccine, cancer, heart disease, HIV/HBV/HCV/TB, VZV seronegative, cytopenias ≥G2, immunosuppression/steroids, MRI issues, allergy to anti‑CD20/natalizumab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Prospective multicenter study in RRMS compares patients starting high-efficacy DMTs: ocrelizumab (humanized anti‑CD20 IgG1 monoclonal antibody), rituximab (chimeric anti‑CD20 IgG1 mAb), ofatumumab (fully human anti‑CD20 IgG1 mAb), and natalizumab (humanized anti‑α4 integrin/VLA‑4 mAb), with matched healthy controls. Primary endpoint: 12‑month changes in B‑cell populations, additional immune, virologic, epigenetic biomarkers plus clinical/MRI outcomes. Targets/pathways: CD20+ B‑cell depletion by ocrelizumab/rituximab/ofatumumab (reduces antigen presentation, proinflammatory cytokines, and B‑cell CNS activity), natalizumab blocks α4β1‑integrin–VCAM‑1 adhesion, inhibiting leukocyte trafficking across the blood–brain barrier and CNS infiltration.