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.
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
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
The study population will consist of male and female adult participants recruited from The Multiple Sclerosis and Neuroimmunology Clinic at The University of Texas Southwestern Medical Center in Dallas, Texas.
Cohort
Prospective
Ravulizumab
DrugAll study participants will receive commercially covered ravulizumab consistent with the indication, dose and frequency contained within the approved label.
Number of participants with clinical relapses before and after treatment with ravulizumab
Compare the number of participants with adjudicated clinical relapses both pre- and post-ravulizumab treatment
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University of Texas Southwestern Medical Center
Lead sponsor
Alexion Pharmaceuticals, Inc.
Collaborator
