Status unknownNMOSDNCT06118398

We could not find results for this trial

I know where the results are

What it found

No result 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 progression
  • Percentage of Participants with Disability Improvement

    1 month, 3 months, 6 months

    Disability progression
  • Change in modified Rankin score (mRS) from baseline.

    1 month, 3 months, 6 months

  • Time to first relapse

    6 months

    Relapses
  • Number of New, and/or Enlarging T2 Hyperintense Lesions Detected by Magnetic Resonance Imaging (MRI)

    6 months

    MRI lesions
  • Change in timed 25 Foot Walk Test from baseline.

    1 month, 3 months, 6 months

    Disability progressionWalking and mobility
  • Number of NMOSD attacked during follow-up

    6 months

    Relapses
  • Change in serum GFAP levels from baseline

    1 month, 6 months

    Blood or spinal fluid markers
  • Change 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

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    Related trials

    History

      1. Started

        Nov 2023

      2. Main results due

        Nov 2024

      3. Finished

        May 2025

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