Not a traditional drug phase: testing Mab Therapy for NMO Spectrum Disorder
The primary objective of this registry study is to measure the therapeutic how well it works and safety profiles of distinct monoclonal antibody-based therapies for aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum disorders within the Chinese population under real-world clinical conditions. Secondary objectives include quantitative assessment of longitudinal neuroimaging biomarker variations and immunological profile alterations in longitudinal biological specimens pre- and post-therapeutic intervention.
Official registry: https://clinicaltrials.gov/study/NCT06885957 · Tongji Hospital · enrollment listed as 200
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 200 people at Wuhan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Registry Study on Monoclonal Antibody-Based Therapies for Aquaporin-4 Antibody-Positive Neuromyelitis Optica Spectrum Disorders
Interventions: Mab Therapy
Primary outcome (registry wording): Time to first relapse
Who it is for (from inclusion criteria)
- Ages 18 Years to 65 Years
- Neurological examination demonstrating clinical stability within 30 days preceding baseline (Visit 1)
Who the registry excludes
- Medical History and Current Health Status
- Prior cerebrovascular events resulting in a baseline modified Rankin Scale (mRS) score \>3
- Hypersensitivity to the investigational therapeutic agent(s) or their excipients
- Documented history or positive screening test for human immunodeficiency virus (HIV)
- Active hepatitis C virus (HCV) infection, defined as detectable HCV RNA with concomitant anti-HCV antibody positivity. Subjects with anti-HCV antibody positivity and undetectable HCV RNA remain eligible
- Chronic, recurrent, or severe infections (e.g., pneumonitis, sepsis) within 90 days prior to baseline (Visit 1)
- History of active tuberculosis (TB) or latent TB infection, defined by positive interferon-gamma release assay (IGRA) results or two consecutive tuberculin skin tests
Contact
No central phone on the registry card. Use the official listing to reach a site.
Sites listed on ClinicalTrials.gov
1 listed- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (recruiting)
FAQ about this NCT record
Is NCT06885957 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06885957?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06885957?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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