HANDLE-a Real World Study on Satralizumab in NMOSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Satralizumab.
- Who it may be relevant to
- Registry conditions: Neuromyelitis Optica Spectrum Disorders (NMOSD). Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real-World Practical Model of Integrated Management for Chinese Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) on Satralizumab
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Proportion of patients relapse-free at 12 months of treatment with satralizumab [Time frame: 12 months]
- Change from baseline in EDSS score at 12 months of treatment with satralizumab [Time frame: 12 months]
Secondary outcome measures (4)
- Proportion of patients relapse-free at 6 months of treatment with satralizumab [Time frame: 6 months]
- Change from baseline in EDSS score at 6 months of treatment with satralizumab [Time frame: 6 months]
- Change patterns from baseline in clinical outcome assessments (COAs) at Months 1, 3, 6, and 12 during satralizumab treatment [Time frame: 1, 3, 6, 12 months]
- Incidence of AEs and SAEs during satralizumab treatment [Time frame: 1, 2, 3, 6, 9, 12 months]
Eligibility criteria
Inclusion criteria
- Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody, ≥ 12 years old;
- EDSS score ≤ 8.5 at baseline;
- Patients have experienced ≥ 1 relapse of NMOSD in the last 12 months or ≥ 2 relapses in the last 24 months;
- Patients should have received or be anticipated to receive satralizumab treatment for at least 12 months;
- 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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Huashan Hospital — Shanghai
Identifiers
NCT: NCT06829524 · KY2024-1393