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Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in Neuromyelitis Optica Spectrum Disorder: A Multicenter Prospective Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Xixi Yang, MD, PhD
xyang891@outlook.com
+86 15601179281
Backup
Zheng Liu, MD, PhD
lzwcy@xwhosp.org
+86 13754093891
Time Frame
Start Date: 2026-07-20
Estimated Completion Date: 2028-01-20
Participants
Target number of participants: 50
Treatments
Satralizumab Treatment Group
NMOSD patients receiving Satralizumab at early phase of an NMOSD attack
Sponsors
Collaborators: The Second Hospital of Hebei Medical University, The First Hospital of Hebei Medical University, First Affiliated Hospital of Harbin Medical University, Chifeng Municipal Hospital, Shandong Provincial Hospital
Leads: Junwei Hao, MD

This content was sourced from clinicaltrials.gov

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