HANDLE-a Real World Study on Satralizumab in NMOSD

NCT06829524 | Not Yet Recruiting

• 1 other identifier: KY2024-1393
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromyelitis Optica Spectrum Disorders (NMOSD)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• Change 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

Study Arms (1)

Satralizumab treatment group

Drug: Satralizumab

Interventions

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.

Satralizumab treatment group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

You may qualify if:

• 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).

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

satralizumab

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Chao Quan, Doctor

  Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China

  PRINCIPAL INVESTIGATOR

• Qiang Dong, Doctor

  Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China

  STUDY CHAIR

• Lei Zhou

  Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China

  STUDY DIRECTOR

• Wenjuan Huang, Doctor

  Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China

  STUDY DIRECTOR

• Jingzi Zhangbao, Doctor

  Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China

  STUDY DIRECTOR

Central Study Contacts

Chao Quan, Doctor

CONTACT

+8613651957283; chao_quan@fudan.edu.cn

Wenjuan Huang, Doctor

CONTACT

+8619921296182; drhuangwenjuan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)