Clinical trial NCT06829524: HANDLE-a Real World Study on Satralizumab in NMOSD
Official title: A Real-World Practical Model of Integrated Management for Chinese Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) on Satralizumab
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neuromyelitis Optica Spectrum Disorders (NMOSD)
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Proportion of patients relapse-free at 12 months of treatment with satralizumab
timeFrame: 12 months
measure: Change from baseline in EDSS score at 12 months of treatment with satralizumab
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients relapse-free at 6 months of treatment with satralizumab
timeFrame: 6 months
measure: Change from baseline in EDSS score at 6 months of treatment with satralizumab
timeFrame: 6 months
measure: Change patterns from baseline in clinical outcome assessments (COAs) at Months 1, 3, 6, and 12 during satralizumab treatment
timeFrame: 1, 3, 6, 12 months
measure: Incidence of AEs and SAEs during satralizumab treatment
timeFrame: 1, 2, 3, 6, 9, 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
name: Chao Quan, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
name: Qiang Dong, Doctor
role: STUDY_CHAIR
affiliation: Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
name: Lei Zhou
role: STUDY_DIRECTOR
affiliation: Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
name: Wenjuan Huang, Doctor
role: STUDY_DIRECTOR
affiliation: Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
name: Jingzi Zhangbao, Doctor
role: STUDY_DIRECTOR
References: