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Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD

Study acronym: BEST-NMOSD
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Aug 1, 2026 to Sep 1, 2026 · Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 11 of 12 entries · 3 more Show 6 more changesShow less
    • Start date changed from estimate of Aug 1, 2026 to Sep 1, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 11 of 12 entries
    • Study description revised
    • Site details revised at 3 of 3 sites
    • Publications: details revised at 25 of 25 entries
  2. Re-verified, no change to tracked fieldsv6
  3. Start date: May 2026 to Aug 1, 2026v5
  4. Enrollment target: 160 to 540v4
  5. Primary completion date: Feb 2029 to Jan 2030 Start date: Nov 2025 to May 2026 · Primary endpoints revised (2) · Completion date: Feb 2030 to May 2030 · 1 morev3 Show 4 more changesShow less
    • Start date: Nov 2025 to May 2026
    • Primary endpoints revised (2)
    • Completion date: Feb 2030 to May 2030
    • Secondary endpoints: 17 to 12

    See this version in full on ClinicalTrials.gov ↗

  6. Secondary endpoints revised (17)v2 See this version in full on ClinicalTrials.gov ↗
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune condition that mainly affects the eyes and spinal cord, causing serious symptoms such as vision loss, paralysis, and severe pain. This trial compares the effectiveness and safety of five medications commonly used to prevent NMOSD relapses: rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab. In this study, 160 adults with NMOSD who test positive for a specific antibody (AQP4-IgG) will participate. They will be randomly assigned to receive either rituximab or one of the four other FDA-approved medications. The main goal is to find out which treatment best prevents relapses and has fewer serious side effects. The trial will also measure disability, patient satisfaction, quality of life, and biomarkers that help track disease activity. Participants will have regular assessments, including medical exams, surveys, and tests for vision, walking ability, and brain function. They will report any side effects or health issues experienced during the study. The trial will last from one to four years for each participant. This research aims to help patients and doctors make better-informed treatment decisions by providing clear evidence about the best available therapies for NMOSD.
Trial Details
NCT Number NCT07010302
Lead Sponsor Massachusetts General Hospital
Collaborators: Patient-Centered Outcomes Research Institute, Charite University, Berlin, Germany, The Sumaira Foundation
Conditions NMOSD
Enrollment 540 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov