Effectiveness and Safety of Efgartigimod in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Controlled, Retrospective, Real-Word Study
Sponsor study identifier
observational
24
0 countries
N/A
Study Start
November 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 5, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study aims to retrospective investigate the safety and effectiveness of Efgartigimod in the acute phase of neuromyelitis optica spectrum disorders (NMOSD) patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2023
Actual (reported)November 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 7, 2023
Actual (reported)November 5, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in Expanded Disability Status Scale (EDSS) score from baseline.
Change in Expanded Disability Status Scale (EDSS) score from baseline to 1 month after treatment (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).
1 month
Change in Expanded Disability Status Scale (EDSS) score from baseline.
3 months, 6 months
Percentage of Participants with Disability Improvement
1 month, 3 months, 6 months
Change in modified Rankin score (mRS) from baseline.
1 month, 3 months, 6 months
Time to first relapse
6 months
Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI)
6 months
Intravenous methylprednisolone (IVMP) plus Efgartigimod
IVMP
IVMP 800-1000mg/day for 3-5 days plus Efgartigimod (Efgartigimod: 10mg/kg IV on Day 1, Day 8, Day 15 and Day 22 after IVMP.)
IVMP 800-1000mg/day for 3-5 days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NMOSD patients with acute attacks
Blood samples are collected before the treatment and at the last visit.
Jinzhou Feng, Ph.D
First Affiliated Hospital of Chongqing Medical University
First Submitted
November 1, 2023
First Posted
November 7, 2023
Study Start
November 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 5, 2024
The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorders
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 5, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 7, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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