Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

This is an observational study to:

* evaluate the on-treatment clinical performance of ravulizumab in relation to the pre-treatment time period (time period prior to exposure), * enhance knowledge regarding conventional MRI outcomes in people with NMOSD treated with ravulizumab, * identify factors suggestive of subclinical disease progression through conventional MRI sequences, * determine if treatment with ravulizumab, impacts longitudinal 3D conformational MRI measures at the dorsal medulla and other regions of the CNS, and * identify biomarkers (e.g., serum neurofilament light chain (sNfL), conventional and novel MRI markers, etc.) related to disease activity.

Eligibility criteria

Qualifiers

Signed informed consent available prior to conduct of any study associated activities

Men and women > 18 years of age

Aquaporin-4 IgG positive people with neuromyelitis optica spectrum disorder treated with commercially available ravulizumab in a manner consistent with the approved indication

Expanded Disability Status Scale score of <7.0

Disqualifiers

Individuals who are intolerant to MRI

Individuals previously exposed to eculizumab with treatment discontinuation due to lack of effective disease control (i.e., clinical relapse or demonstration of MRI advancement after 12 weeks of sustained treatment exposure)

Unresolved meningococcal disease

History of an active infection

Trial design

Treatments tested in this trial

  • Ravulizumab

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Texas Southwestern Medical Center

Lead sponsor

Alexion Pharmaceuticals, Inc.

Collaborator