RecruitingNot Applicable

Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD

China200 participantsStarted 2025-07-01

Plain-language summary

The primary objective of this registry study is to evaluate the therapeutic efficacy 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Clinically significant medical history of cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, renal, pulmonary, neurological, dermatologic, psychiatric, or other major systemic conditions that, in the investigator's judgment, would preclude safe trial participation.
✕. 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.
✕. Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity and/or total hepatitis B core antibody (anti-HBc) positivity. Subjects with prior natural infection (HBsAg-negative, anti-HBc-positive, and anti-HBs-positive) or vaccination-induced immunity (HBsAg-negative, anti-HBc-negative, and anti-HBs-positive) are 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.

What they're measuring

Time to first relapse

Timeframe: Up to 96 weeks

Median time to relapse

Timeframe: Up to 96 weeks

Annualized relapse rate

Timeframe: Up to 96 weeks

EDSS score

Timeframe: Up to 96 weeks

Trial details

NCT IDNCT06885957

SponsorTongji Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More NMO Spectrum Disorder trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Clinically significant medical history of cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, renal, pulmonary, neurological, dermatologic, psychiatric, or other major systemic conditions that, in the investigator's judgment, would preclude safe trial participation.
✕. 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.
✕. Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity and/or total hepatitis B core antibody (anti-HBc) positivity. Subjects with prior natural infection (HBsAg-negative, anti-HBc-positive, and anti-HBs-positive) or vaccination-induced immunity (HBsAg-negative, anti-HBc-negative, and anti-HBs-positive) are 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.