HANDLE-a Real World Study on Satralizumab in NMOSD
NCT06829524 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2025-03-18
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)
Interventions
- 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.
Sponsors & Collaborators
-
Huashan Hospital
lead OTHER
Principal Investigators
-
Chao Quan, Doctor · Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
-
Qiang Dong, Doctor · Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
-
Lei Zhou · Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
-
Wenjuan Huang, Doctor · Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
-
Jingzi Zhangbao, Doctor · Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-31
- Primary Completion
- 2027-03-31
- Completion
- 2027-06-30
Countries
- China
Study Locations
More Related Trials
-
An Open Label Study of the Effects of SHR1459 in NMOSDs Patients
NCT04670770 ·Status: COMPLETED ·Phase: PHASE2
-
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis
NCT05214794 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of Fingolimod in MS Patients in China
NCT01941004 ·Status: WITHDRAWN ·Phase: PHASE3
-
Treatment Response Among Chinese Neuromyelitis Optica Spectrum Disorders
NCT04101058 ·Status: UNKNOWN
-
Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD)
NCT05551598 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection.
NCT06982534 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients
NCT02809079 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study to Evaluate the Efficacy and Safety of JYP0061 in Patients With Acute Neuromyelitis Spectrum Disease (NMOSD)
NCT06697535 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders
NCT02021825 ·Status: UNKNOWN ·Phase: PHASE4
-
Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis
NCT01547234 ·Status: COMPLETED
-
The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis
NCT06599307 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Monoclonal Antibody in Acute Phase of Neuromyelitis Optica Spectrum Disorder
NCT07182409 ·Status: NOT_YET_RECRUITING
-
Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS
NCT06334094 ·Status: WITHDRAWN ·Phase: PHASE4
-
Safety of Therapeutic Step-down in Neuromyelitis Optica
NCT05155644 ·Status: COMPLETED
-
Evaluation of Natalizumab for thE Relief of MS Associated FatiGue
NCT00464074 ·Status: COMPLETED
-
CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
NCT04886492 ·Status: ENROLLING_BY_INVITATION
-
Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients Treated With Teriflunomide and Alemtuzumab
NCT05075499 ·Status: UNKNOWN ·Phase: NA
-
Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS
NCT02259361 ·Status: UNKNOWN ·Phase: PHASE4
-
Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis
NCT01435993 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Assess COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab
NCT06460324 ·Status: COMPLETED
-
A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese Adults With Relapsing Multiple Sclerosis
NCT06396039 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder
NCT06561009 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Multiple Sclerosis Versus Neuromyelitis Optica Spectrum Disorder
NCT07304960 ·Status: NOT_YET_RECRUITING
-
A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSD
NCT03062579 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
NCT00559702 ·Status: COMPLETED ·Phase: PHASE1