Efgartigimod in Acute Neuromyelitis Optica Spectrum Disorders
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Methylprednisolone
Glucocorticoid receptor agonist
What it measured
Main measures
Change in Expanded Disability Status Scale (EDSS) score from baseline.
1 month
Disability progression
Other measures (14)
Change in Expanded Disability Status Scale (EDSS) score from baseline.
3 months, 6 months
Disability progressionPercentage of Participants with Disability Improvement
1 month, 3 months, 6 months
Disability progressionChange in modified Rankin score (mRS) from baseline.
1 month, 3 months, 6 months
Time to first relapse
6 months
RelapsesNumber of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI)
6 months
MRI lesionsChange in timed 25 Foot Walk Test from baseline.
1 month, 3 months, 6 months
Disability progressionWalking and mobilityNumber of NMOSD attacked during follow-up
6 months
RelapsesChange in serum GFAP levels from baseline
1 month, 6 months
Blood or spinal fluid markersChange in AQP4-ab titres from baseline
1month, 6 months
Change in serum NfL levels from baseline
1 month, 6 months
Blood or spinal fluid markers
Who could take part
NMOSD · 18 and over
Inclusion Criteria: * 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis). * 2. Patients in the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before received treatment, lasting at least 24 hours without fever), who had poor response to IVMP and without having received second-line therapies such as plasma exchange or intravenous immunoglobulin consequencely (Poor response is defined as a reduction in EDSS score of: I. \<1.0 from the baseline EDSS score when the baseline score was \<=5.5 II. \< 0.5 when the baseline EDSS score > 5.5). * 3. Patients who were approved for Efgartigimod treatment would be enrolled in the exposed group. * 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 before treatment. * 5. Patients have given their written informed consent. Exclusion Criteria: * 1. Lactating and pregnant females before treatment. * 2. Participated in other interventional studies within 30 days before treatment. * 3. Received plasma exchange, immunoadsorption, or intravenous immunoglobulin (IVIG) therapy within 1 month before treatment. * 4. History of malignancies. * 5. Combined with severe mental disorders and other conditions that unable to cooperate with follow-up. * 6. After being evaluated by experts, patients with active hepatitis, active tuberculosis, or other special conditions which were ineligible to participate in this study.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study aims to retrospective investigate the safety and effectiveness of Efgartigimod in the acute phase of neuromyelitis optica spectrum disorders (NMOSD) patients.
Papers
Loading reviews and guidelines…
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History
Started
Nov 2023
Main results due
Nov 2024
Finished
May 2025
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