HANDLE-a Real World Study on Satralizumab in NMOSD

Not yet recruiting

• Conditions: Neuromyelitis Optica Spectrum Disorders (NMOSD)
• Interventions: Drug: Satralizumab

• Registration Number: NCT06829524
• Lead Sponsor: Huashan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Study Start: 2025-03-31
• Primary Completion: 2027-03-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Satralizumab treatment group	Satralizumab	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients relapse-free at 12 months of treatment with satralizumab	12 months
Change from baseline in EDSS score at 12 months of treatment with satralizumab	12 months

Secondary Outcome Measures

Name	Time	Method
Change patterns from baseline in clinical outcome assessments (COAs) at Months 1, 3, 6, and 12 during satralizumab treatment	1, 3, 6, 12 months
Proportion of patients relapse-free at 6 months of treatment with satralizumab	6 months
Change from baseline in EDSS score at 6 months of treatment with satralizumab	6 months
Incidence of AEs and SAEs during satralizumab treatment	1, 2, 3, 6, 9, 12 months	Adverse events were coded using MedDRA version 27.1. Adverse events were analyzed in the safety analysis population (all patients who received at least one dose of study treatment) in terms of percentage incidence and as rates by exposure time (number of events per 100 patient-years of exposure and the associated 95% CI) to adjust for any differences in duration of exposure. The severity of adverse events was measured by NCI CTCAE version 5.0.

Trial Locations

Locations (2)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China