AMAZE
What it found
No result yet.
What was tested
Treatment tested
- Ravulizumab
Complement C5 inhibitor
What it measured
Main measures
Number of participants with clinical relapses before and after treatment with ravulizumab
52 weeks - 78 weeks in primary phase, 78 weeks in extension phase.
Relapses
Who could take part
NMOSD · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Jul 2024
Main results due
Apr 2029
Finished
Oct 2029
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