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Recruiting
NCT06829524
HANDLE-a Real World Study on Satralizumab in NMOSD
Conditions: Neuromyelitis Optica Spectrum Disorders (NMOSD)
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Huashan Hospital
Location: Huashan Hospital Shanghai Shanghai Municipality
Summary
This study is a single-center, retrospective-prospective, non-interventional cohort study to assess the clinical outcomes of Chinese NMOSD patients treated with satralizumab in a real-world patient management model by collecting follow-up data in clinical practice.
Eligibility Criteria
Inclusion Criteria:
1. Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody, ≥ 12 years old;
2. EDSS score ≤ 8.5 at baseline;
3. Patients have experienced ≥ 1 relapse of NMOSD in the last 12 months or ≥ 2 relapses in the last 24 months;
4. Patients should have received or be anticipated to receive satralizumab treatment for at least 12 months;
5. Patients understand the study procedures and sign the informed consent form indicating willingness to participate in the study (for those \< 18 years of age, the guardian should sign the informed consent form on behalf of the patient).
Exclusion Criteria:
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Source: ClinicalTrials.gov (NCT06829524). StuddyBuddy aggregates publicly available trial information.