Neuromyelitis Optica Spectrum Disorders (NMOSD)SATURNNCT07762872
A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD
An observational study of Neuromyelitis Optica Spectrum Disorders (NMOSD), run by Junwei Hao, MD at 1 site in China.
Trial summary
This study is a multicenter, prospective cohort study designed to enroll 50 NMOSD patients who receive Satralizumab treatment during the early phase of an NMOSD attack. Follow-up visits will be conducted at baseline, 3 months, and 6 months to record and assess EDSS scores, modified Rankin Scale (mRS) scores, EQ-5D… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders (NMOSD)
- What is being tested?
- Satralizumab
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 20 Jan 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NMOSD (AQP4-IgG-positive) at early phase of an NMOSD attack, and age ≥ 18 years. The EDSS score ≤ 8.5 during an acute relapse in NMOSD.
Who may be able to join
- Diagnosis of AQP4-IgG-positive NMOSD* and age ≥ 18 years; EDSS score ≤ 8.5 during an acute relapse in NMOSD patients; NMOSD patients experiencing an acute relapse who are scheduled to receive or are currently receiving recommended acute-phase treatments-including intravenous methylprednisolone, IVIG, PE, or PA; Receiving Satralizumab treatment; Patient understands the study procedures and has signed the informed consent form indicating willingness to participate in the study.
Who cannot join
- Patients with NMOSD who received other biologics (e.g., rituximab, inebilizumab, tocilizumab, eculizumab) either within the past 6 months prior to this acute exacerbation or during the current acute phase; Patients with contraindications to Satralizumab, including: known allergy to Satralizumab or any inactive ingredient, active Hepatitis B infection, active or therapy-naive latent tuberculosis; Pregnant or lactating women; Patients with concomitant Neoplasm malignant or other severe diseases; Patients currently enrolled in other interventional clinical studies; Patients assessed by the investigator/research staff as having a Critical illness or any Mental disorder or Cognitive disorder that may interfere with the study and who are unable to complete the key assessments required by this protocol; patients assessed by the investigator/research staff as unlikely to attend scheduled follow-up assessments under routine clinical care.
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
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Xixi Yang, MD, PhD, +8615601179281, xyang891@outlook.com
Zheng Liu, MD, PhD, +8613754093891, xyang891@outlook.com
About this study
Official title: Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Cohort Study
This study is a multicenter, prospective cohort study designed to enroll 50 NMOSD patients who receive Satralizumab treatment during the early phase of an NMOSD attack. Follow-up visits will be conducted at baseline, 3 months, and 6 months to record and assess EDSS scores, modified Rankin Scale (mRS) scores, EQ-5D scores, Activities of Daily Living (ADL) scores, relapse events, safety data, and exploratory endpoints (e.g., blood inflammatory markers and visual function), with the aim of evaluating the efficacy and safety of Satralizumab in the early treatment of NMOSD-thereby providing patients with more effective therapeutic options and further optimizing the clinical management of NMOSD.
- Being tested
- Satralizumab
- Keywords
- NMOSD, 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
As recommended in the prescribing information, patients will receive subcutaneous satralizumab Injection as part of their routine treatment. The loading dose is 120 mg administered at Weeks 0, 2, and 4, followed by a maintenance dose of 120 mg every 4 weeks. Maintenance treatment is recommended for a minimum duration of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Satralizumab Treatment Group | NMOSD patients receiving Satralizumab at early phase of an NMOSD attack Receives: Drug: Satralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
EDSS
Change in EDSS score between at baseline and at 6 months of treatment
Measured: 24 weeks
Secondary outcomes (8)
EDSS
Change in EDSS score between at baseline and at 3 months of treatment
Measured: 12 weeks
mRS
Changes in mRS between at baseline and at 3 months of treatment
Measured: 12 weeks
EQ-5D
Changes in EQ-5D between at baseline and at 3 months of treatment
Measured: 12 weeks
ADL score
Changes in ADL score between at baseline and at 3 months of treatment
Measured: 12 weeks
mRS
Changes in mRS between at baseline and at 6 months of treatment
Measured: 24 weeks
EQ-5D
Changes in EQ-5D between at baseline and at 6 months of treatment
Measured: 24 weeks
ADL score
Changes in ADL score between at baseline and at 6 months of treatment
Measured: 24 weeks
relapse
Relapse events occurring within 6 months of treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start20 Jul 2026
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jan 2028 (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.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Junwei Hao, MD
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Hebei Medical University, The Second Hospital of Hebei Medical University, First Affiliated Hospital of Harbin Medical University, Shandong Provincial Hospital, Chifeng Municipal Hospital
- Responsible party
- Sponsor-investigator, Junwei Hao, MD, Xuanwu Hospital, Beijing
- Investigators
- Junwei Hao, MD, PhD, Principal investigator, Xuanwu Hospital Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762872
- Sponsor's protocol ID
- xw-[2025]291-001
- Acronym
- SATURN
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual's age, gender, EDSS, mRS, ADL, EQ-5D, laboratory parameters and adverse event records, etc.