Neuromyelitis Optica Spectrum Disorders (NMOSD)NCT06829524
HANDLE-a Real World Study on Satralizumab in NMOSD
An observational study of Neuromyelitis Optica Spectrum Disorders (NMOSD), run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders (NMOSD)
- What is being tested?
- Satralizumab
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Ying Mao, +86 52888828, maoying@fudan.edu.cn
About this study
Official title: A Real-World Practical Model of Integrated Management for Chinese Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) on Satralizumab
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.
- Being tested
- Satralizumab
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SatralizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Satralizumab treatment group | Not described Receives: Drug: Satralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients relapse-free at 12 months of treatment with satralizumab
Measured: 12 months
Change from baseline in EDSS score at 12 months of treatment with satralizumab
Measured: 12 months
Secondary outcomes (4)
Proportion of patients relapse-free at 6 months of treatment with satralizumab
Measured: 6 months
Change from baseline in EDSS score at 6 months of treatment with satralizumab
Measured: 6 months
Change patterns from baseline in clinical outcome assessments (COAs) at Months 1, 3, 6, and 12 during satralizumab treatment
Measured: 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.
Measured: 1, 2, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start31 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum Disorders (NMOSD)Studies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Quan, Huashan Hospital
- Investigators
- Chao Quan, Doctor, Principal investigator, Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of ChinaQiang Dong, Doctor, Study chair, Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of ChinaLei Zhou, Study director, Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of ChinaWenjuan Huang, Doctor, Study director, Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of ChinaJingzi Zhangbao, Doctor, Study director, Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829524
- Sponsor's protocol ID
- KY2024-1393
- Status last verified
- Sep 2026
- First submitted
- 11 Feb 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Practical Model of Integrated Management for Chinese Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) on Satralizumab
- ClinicalTrials.gov ID
- NCT06829524
- Acronym / sponsor ID
- KY2024-1393
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Satralizumab treatment group | – | Drug: Satralizumab |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SatralizumabSatralizumab 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. | Drug | Satralizumab treatment group |
Primary outcome
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
4 secondary outcomes
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
Time frame: 1, 2, 3, 6, 9, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Quan, Doctor principal investigator
Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
Qiang Dong, Doctor study chair
Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
Lei Zhou study director
Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica Spectrum Disorders (NMOSD), run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Quan, Doctor (+8613651957283, chao_quan@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients relapse-free at 12 months of treatment with satralizumab (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.