What this study is
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.
What's being tested
- Rituximab (R)
Intervention · DRUG
1000 mg at weeks 0 and 2 followed by 1000 mg every 6 months
- Eculizumab (Soliris®)
Intervention · DRUG
900 mg weekly for 4 weeks, followed by 1200 mg every 2 weeks
- Ravulizumab
Intervention · DRUG
* 40 to < 60 kg: 2400 mg * 60 to < 100 kg: 2700 mg * 100 kg: 3000 mg as an induction dose, followed by * 40 to < 60 kg: 3000 mg * 60 to < 100 kg: 3300 mg * 100 kg: 3600 mg Every 8 weeks starting 15 days after loading dose
- Satralizumab
Intervention · DRUG
120 mg at Weeks 0, 2, 4, followed by 120 mg every 4 weeks
- Inebilizumab
Intervention · DRUG
300 mg on Day 1 and Day 15, followed by 300 mg every 6 months
Study details
- Official title
- A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder
- Sponsor
- Massachusetts General Hospital
- Conditions
- NMOSD
- Enrolling
- 540 people
- Starts
- 2026-09-01
- Est. completion
- 2030-05
- Design
- Double-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Diagnosis of NMOSD according to the 2015 International Panel for NMO Diagnosis (IPND) consensus criteria.
- Seropositivity for AQP4 immunoglobulin G (AQP4-IgG) confirmed by a cell-based assay (either live or fixed) that meets the threshold for positivity set by the local testing laboratory.
- Age ≥18 years at the time of consent.
- Ability and willingness to provide informed consent and comply with all study procedures, including scheduled visits, laboratory tests, and assessments.
- Eligible to receive any of the study drugs based on clinical judgment
You can't join if
- Known active hepatitis B virus (HBV) infection, defined as a positive hepatitis B surface antigen or detectable HBV DNA by PCR.
- Known active hepatitis C virus (HCV) infection, defined as detectable HCV RNA by PCR.
- Known active or latent tuberculosis, evidenced by a positive interferon-gamma release assay (IGRA) unless fully treated per local guidelines before enrollment.
- Known or suspected immunodeficiency disorders, including but not limited to HIV infection with CD4 count <200 cells/mm³ or any condition requiring chronic immunosuppressive therapy outside the scope of the study drugs.
- Pregnancy or breastfeeding, or intention to conceive during the study period. Pregnancy is excluded due to insufficient safety data for the investigational treatments in this population. Women of childbearing potential must agree to use effective contraception throughout the study and for a defined period following the last dose of study drug, per product labeling or institutional guidance.
- Any medical, psychiatric, or neurological condition that, in the investigator's opinion, may interfere with study participation, pose additional risk to the participant, or confound interpretation of study results.
- Inability or unwillingness to comply with the requirements of the protocol, including scheduled visits, evaluations, or procedures, based on investigator assessment.
- Known hypersensitivity or severe allergic reaction to any component of the study drugs or pre-medications required for infusion.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openMassachusetts General Hospital
Boston, Massachusetts, United States
- Michael Levy, MD · Contact(617) 726-7565mlevy11@mgh.harvard.edu
RecruitingBrigham and Women's Hospital
Boston, Massachusetts, United States
- Shamik Bhattacharyya, MD · Contact(617) 726-7565sbhattacharyya3@bwh.harvard.edu
Recruiting
1 site outside the US
Charité - Universitätsmedizin Berlin
Berlin, Germany
- Friedemann, Paul · Contact+49 30 450 539 705friedemann.paul@charite.de
Not yet recruiting
Study team
Sponsor
Massachusetts General Hospital
Study ID 40200
Principal investigator
Philippe-Antoine Bilodeau, MD
Massachusetts General Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.