HANDLE-a Real World Study on Satralizumab in NMOSD

Fudan University

Status: Not yet enrolling

Conditions: Neuromyelitis Optica Spectrum Disorders (NMOSD)

Treatments: Drug: Satralizumab

Study type: Observational

Funder types: Other

Identifiers

NCT06829524

KY2024-1393

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Satralizumab treatment group

Treatment:

Drug: Satralizumab