Efficacy and Safety of Monoclonal Antibody in Acute Phase of Neuromyelitis Optica Spectrum Disorder (NCT07182409) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Monoclonal Antibody in Acute Phase of Neuromyelitis Optica Spectrum Disorder
40 participantsStarted 2025-10-01
Plain-language summary
This study aims to evaluate the efficacy and safety of different monoclonal antibody in the acute phase of neuromyelitis optica spectrum disorder (MAAP-NMO). It will also examine immune-related biomarkers and their relationship with treatment response to provide evidence for optimizing acute-phase therapeutic strategies.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age at onset ≥18 years, any gender.
✓. Patients meeting the 2015 International Panel for NMO Diagnosis (IPND) criteria for NMOSD and currently in the acute phase, defined as new or significantly worsened neurological deficits lasting \>24 hours, with onset within \<14 days, excluding pseudo-relapses caused by fever, infection, or metabolic disturbances. The acute relapse must meet at least one of the following clinical phenotypes: a) Optic neuritis (ON): EDSS visual function score ≥3; b) Transverse myelitis (TM): EDSS pyramidal function score ≥2. NMOSD-related syndromes (e.g., area postrema syndrome, acute brainstem syndrome, acute diencephalic syndrome, cerebral syndrome) may be present as concomitant features but cannot be the sole or primary manifestation.
✓. Serum AQP4-IgG positive by cell-based assay (CBA) with a titer ≥1:32, and negative for MOG-IgG (CBA or LCBA) and GFAP-IgG.
✓. Expanded Disability Status Scale (EDSS) score at enrollment ≥3 and ≤8 points.
✓. Planned to receive or currently receiving intravenous methylprednisolone (IVMP) treatment, and not on or only using conventional immunosuppressive maintenance therapy.
✓. Able to comply with standardized follow-up, with an expected minimum follow-up of 12 months during the study period.
✓. Signed informed consent by the patient or legal guardian (if applicable).
Exclusion criteria
✕. Participation in a randomized clinical trial with blinded treatment allocation.
✕. Received treatment with monoclonal antibody (including rituximab, satralizumab, inebilizumab, eculizumab, efgartigimod, etc.) within 3 months prior to screening.
What they're measuring
1
Change in Expanded Disability Status Scale (EDSS) score
Timeframe: 1 months
Trial details
NCT IDNCT07182409
SponsorFirst Affiliated Hospital of Chongqing Medical University
✕. Received treatment with IVIg, plasma exchange (PE), IVMP, or oral corticosteroids \>30 mg/day within 1 month prior to screening.
✕. Incomplete or unavailable follow-up data, expected inability to complete follow-up, or poor compliance.
✕. Patients who have independently discontinued immunotherapy or demonstrate poor adherence.
✕. Presence of severe underlying diseases or other conditions that may affect the safety of immunotherapy or the interpretation of study results, including but not limited to: a) Chronic or active infections requiring long-term systemic treatment (e.g., progressive multifocal leukoencephalopathy, chronic renal infection, chronic respiratory infection with bronchiectasis, active tuberculosis, active hepatitis C, etc.); b) Positive hepatitis B serology (except in individuals with prior vaccination); c) History or suspicion of tuberculosis; d) Positive HIV serology; e) History or current clinically significant adverse reactions (including severe allergic reactions) related to corticosteroids, FcRn antagonists, or complement inhibitors.
✕. Pregnant or breastfeeding women, or women planning pregnancy in the near future (contraception required during treatment).
✕. Any other condition deemed by the investigators to make participation in the study inappropriate.