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NCT Number: NCT06829524

HANDLE-a Real World Study on Satralizumab in NMOSD

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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Key information

Conditions

Neuromyelitis Optica Spectrum Disorders (NMOSD) Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Quan, Doctor

CONTACT

[email protected]

+8613651957283

Wenjuan Huang, Doctor

CONTACT

[email protected]

+8619921296182

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

A Real-World Practical Model of Integrated Management for Chinese Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) on Satralizumab

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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