HANDLE-a Real World Study on Satralizumab in NMOSD
What it found
No result yet.
What was tested
Treatment tested
- Satralizumab
IL6Ralpha/GP130 antagonist
What it measured
Main measures
Proportion of patients relapse-free at 12 months of treatment with satralizumab
12 months
RelapsesChange from baseline in EDSS score at 12 months of treatment with satralizumab
12 months
Disability progression
Other measures (4)
Proportion of patients relapse-free at 6 months of treatment with satralizumab
6 months
RelapsesChange from baseline in EDSS score at 6 months of treatment with satralizumab
6 months
Disability progressionChange patterns from baseline in clinical outcome assessments (COAs) at Months 1, 3, 6, and 12 during satralizumab treatment
1, 3, 6, 12 months
Incidence of AEs and SAEs during satralizumab treatment
1, 2, 3, 6, 9, 12 months
Safety
Who could take part
NMOSD · 12 and over
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: -
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Mar 2025
Main results due
Mar 2027
Finished
Jun 2027
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