Health TrialsbyHealthPanel

HANDLE-a Real World Study on Satralizumab in NMOSD

ConditionNeuromyelitis Optica Spectrum Disorders (NMOSD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorHuashan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial population

This study is a real-world study and will enroll patients diagnosed with NMOSD who are AQP4-IgG positive and receiving satralizumab in routine clinical practice in China

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Satralizumab

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Satralizumab treatment group1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients relapse-free at 12 months of treatment with satralizumab

Time frame
12 months
2

Change from baseline in EDSS score at 12 months of treatment with satralizumab

Time frame
12 months

Secondary outcomes

1

Proportion of patients relapse-free at 6 months of treatment with satralizumab

Time frame
6 months
2

Change from baseline in EDSS score at 6 months of treatment with satralizumab

Time frame
6 months
3

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
4

Incidence of AEs and SAEs during satralizumab treatment

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.

Time frame
1, 2, 3, 6, 9, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huashan Hospital

Lead sponsor

Source ClinicalTrials.gov
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