A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD

NCT07762872 | Recruiting FDA Drug

• 1 other identifier: xw-[2025]291-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Neuromyelitis Optica Spectrum Disorders (NMOSD)

Keywords

NMOSD; Satralizumab

Outcome Measures

Primary Outcomes (1)

• EDSS

  Change in EDSS score between at baseline and at 6 months of treatment

  24 weeks

Secondary Outcomes (8)

• EDSS

  12 weeks

• mRS

  12 weeks

• EQ-5D

  12 weeks

• ADL score

  12 weeks

• mRS

  24 weeks

Study Arms (1)

Satralizumab Treatment Group

NMOSD patients receiving Satralizumab at early phase of an NMOSD attack

Drug: Satralizumab

Interventions

Satralizumab DRUG

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.

Satralizumab Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Junwei Hao, MD: lead
• The First Hospital of Hebei Medical University: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• First Affiliated Hospital of Harbin Medical University: collaborator
• Shandong Provincial Hospital: collaborator
• Chifeng Municipal Hospital: collaborator

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

satralizumab

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Junwei Hao, MD, PhD

  Xuanwu Hospital Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xixi Yang, MD, PhD

CONTACT

+86 15601179281; xyang891@outlook.com

Zheng Liu, MD, PhD

CONTACT

+86 13754093891; lzwcy@xwhosp.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 13, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): January 20, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)