Clinical and Radiological Outcomes in People With Aquaporin-4 IgG Positive Neuromyelitis Optica Spectrum Disorder Treated With Ravulizumab

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Diem Tran, PhD
diemh.tran@utsouthwestern.edu
214-645-9165
Backup
Jose Santoyo
jose.santoyo@utsouthwestern.edu
214-645-1878
Time Frame
Start Date: 2024-07-10
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 35
Treatments
NMOSD
35 people with aquaporin-4 IgG antibody positive neuromyelitis optica spectrum disorder is planned with all individuals treated with commercially supplied ravulizumab at the recommendation of the healthcare provider, with use consistent with the approved indication and labeling. Approximately 50% of the cohort is anticipated to be Black/African American based on existing internal data.
Sponsors
Leads: University of Texas Southwestern Medical Center
Collaborators: Alexion Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov