Rituximab vs multiple approved NMOSD therapies to prevent relapses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, multicenter, adaptive trial compares rituximab with ravulizumab, inebilizumab, satralizumab, and eculizumab in adults with AQP4-IgG-positive NMOSD. It randomizes participants to either rituximab or one of the four alternative treatments, with a parallel observational cohort for those who decline randomization. The primary goal is to see which treatment best prevents relapses while minimizing serious adverse events, with secondary measures including disability, quality of life, safety, and disease activity biomarkers. Participants undergo regular clinical exams, imaging, vision and mobility assessments, and patient-reported outcomes to track response and tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Charité - Universitätsmedizin Berlin
  Berlin, Germany Not yet recruiting

Study contacts

• Principal investigator: Philippe-Antoine Bilodeau, MD — Massachusetts General Hospital
• Study coordinator: Philippe-Antoine Bilodeau, MD
• Email: pbilodeau@mgh.harvard.edu
• Phone: 617-726-7565

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ravulizumab in Chinese adults with NMOSD

  This study tests ravulizumab in Chinese adults with NMOSD who are AQP4 antibody positive to see if it helps reduce relapses and is safe.

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• Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL

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• Chidamide, Lenalidomide, and Rituximab as induction therapy for newly diagnosed elderly or unfit double-expressor DLBCL

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• Inebilizumab for Type 1 Autoimmune Pancreatitis in Adults

  This study tests whether inebilizumab can help adults with type 1 autoimmune pancreatitis by reducing relapses when paired with a standardized steroid taper.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.