HANDLE-a Real World Study on Satralizumab in NMOSD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Neuromyelitis Optica Spectrum Disorders (NMOSD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Satralizumab treatment group

Satralizumab

Intervention Type DRUG

Satralizumab is the first monoclonal antibody approved for the treatment of NMOSD in China. Currently, there is still a lack of standard patient management pattern for NMOSD. While satralizumab offers the advantage of home administration, there remains a pressing need for optimized patient management.

Interventions

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Satralizumab

Satralizumab is the first monoclonal antibody approved for the treatment of NMOSD in China. Currently, there is still a lack of standard patient management pattern for NMOSD. While satralizumab offers the advantage of home administration, there remains a pressing need for optimized patient management.

Intervention Type DRUG

Eligibility Criteria

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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

\-

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Chao Quan

Professor, Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR