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

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Apr 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called ravulizumab on people with a condition known as Neuromyelitis Optica Spectrum Disorder (NMOSD). The goal of the study is to understand how well ravulizumab works compared to the time before patients started taking the medication. Researchers will also look at MRI scans to learn more about changes in the brain and spinal cord while patients are receiving treatment. Additionally, they aim to identify specific markers in the blood and MRI scans that can indicate disease activity and progression.

To participate in this study, individuals must be at least 18 years old, have a specific antibody related to NMOSD, and be currently treated with ravulizumab. They should have a certain level of disability (measured by a scale that ranges from 0 to 10, with 0 being no disability and 10 being the most severe). However, individuals who have had adverse reactions to MRI, have been previously treated with a similar drug without success, or have certain health issues, including infections or pregnancy, cannot join the study. Participants will help researchers gather valuable information and may contribute to better understanding and treatment options for NMOSD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent available prior to conduct of any study associated activities
• • 2. Men and women \> 18 years of age
• • 3. Aquaporin-4 IgG positive people with neuromyelitis optica spectrum disorder treated with commercially available ravulizumab in a manner consistent with the approved indication
• • 4. Expanded Disability Status Scale score of \<7.0
• Exclusion Criteria:
• • 1. Individuals who are intolerant to MRI
• • 2. 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)
• • 3. Unresolved meningococcal disease
• • 4. History of an active infection
• • 5. Existing participation in neuromyelitis optical spectrum disorder interventional clinical studies
• • 6. Pregnant or lactating women