Ignite Creation Date:
2024-05-06 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05269667
Status:
TERMINATED
Last Update Posted:
2023-11-08
First Post:
2022-02-15
Brief Title:
A Study In Neuromyelitis Optica Spectrum Disorder NMOSD With Satralizumab As An Intervention
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
SAkuraBonsai Clinical Imaging And Biomarker Open-Label Study In Neuromyelitis Optica Spectrum Disorder NMOSD With Satralizumab As An Intervention
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study has proved infeasible to recruit in sufficient numbers There are insufficient eligible patients presenting to sites
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAkuraBonsai
Brief Summary:
Objective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 AQP4 antibody seropositive NMOSD either treatment naive or inadequate responders to previous treatment with rituximab RTX or its biosimilar
Detailed Description:
Neuromyelitis optica NMO and neuromyelitis optica spectrum disorder NMOSD are severe demyelinating inflammatory autoimmune neurological disorders The estimated global pooled prevalence of NMOSD is 182 per 100 000 people Etemadifar et al 2015 The disorder is characterized by inflammatory lesions in the optic nerve spinal cord brainstem and cerebrum and clinically by optic neuritis ON andor transverse myelitis causing potentially severe motor and sensory impairment bladder dysfunction vision loss pain and other debilitating symptoms Wingerchuk et al 2015 Recovery is variable and inflammatory attacks often result in permanent disability Untreated the risks of severe disability or death are substantial Jarius et al 2014
NMOSD is radiologically and prognostically distinct from multiple sclerosis MS and has a pathophysiology unresponsive to typical MS treatment Weinshenker 2007 Oh and Levy et al 2012
NMOSD is radiologically and prognostically distinct from multiple sclerosis MS and has a pathophysiology unresponsive to typical MS treatment Weinshenker 2007 Oh and Levy et al 2012
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-001088-26 | EUDRACT_NUMBER | None | None |