An observational study in Neuromyelitis Optica Spectrum Disorders (NMOSD), sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Huashan Hospital · Observational
Among 72 studies in Neuromyelitis Optica with a site in China — 37 open to participants now, 43 under way, 7 of them phase 3. Neuromyelitis Optica · China.
Among the 72 studies in Neuromyelitis Optica with a site in China, this one is the 16th largest by planned enrollment of the 21 observational ones that give a count, is one of 10 that started in 2025, is one of 21 observational ones, reaches primary completion later than 18 of the 42 other live ones, and was the 55th registered.
178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.
Browse Neuromyelitis Optica studies →37 of the 72 studies in Neuromyelitis Optica with a site in China are open now. Recruiting first, the newest first:
Alexion Pharmaceuticals, Inc. · Sites in China
Junwei Hao, MD · Sites in China
Hoffmann-La Roche · Sites in China, United States, Argentina and 6 more countries
Tongji Hospital · Sites in China
Chinese PLA General Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 50 Neuromyelitis Optica studies recruiting now, 29 (58%) set no upper age limit and 16 (32%) stop at 75 or younger; 11 take children under 18; 9 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
72 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 17 · Phase 3 9 · Phase 4 6
First in 2009; this study’s year is marked. 10 started in 2025.
This study's planned enrollment of 100 is below the median of 200 across 62 observational studies indexed under Neuromyelitis Optica.
Median enrollment 23 across the 51 interventional studies, 300 across the 21 observational. Of the 17 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 72 have an industry lead sponsor. The 10 most frequent:
Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.
Huashan Hospital has 3 studies filed under Neuromyelitis Optica — fewer than ten, so there is no comparison to draw.
19 of the studies in Neuromyelitis Optica with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06724809Phase 3Alexion Pharmaceuticals, Inc.Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD | 2026-12-07 |
| NCT07420296Phase 3Tianjin Medical University General HospitalModified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder | 2026-12-31 |
| NCT05199688Phase 3Hoffmann-La RocheA Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) | 2027-03-31 |
| NCT06413654Phase 3Shanghai Jiaolian Drug Research and Development Co., LtdA Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD) | 2027-10-31 |
| NCT05145361Shanghai Pharmaceuticals Holding Co., LtdClinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) | 2026-12-15 |
Among the 72 studies in Neuromyelitis Optica with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Satralizumab
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.
Proportion of patients relapse-free at 12 months of treatment with satralizumab
Time frame: 12 months
Change from baseline in EDSS score at 12 months of treatment with satralizumab
Time frame: 12 months
Proportion of patients relapse-free at 6 months of treatment with satralizumab
Time frame: 6 months
Change from baseline in EDSS score at 6 months of treatment with satralizumab
Time frame: 6 months
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
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