Satralizumab in NMOSD: Real-world outcomes from China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, non-interventional study combining retrospective and prospective data to observe clinical outcomes in seropositive NMOSD patients treated with satralizumab in a real-world setting. Participants are followed to collect information from routine clinical practice, focusing on relapses and disability over time. The study does not assign treatments or protocols beyond standard care, and data are drawn from medical records and follow-up visits. Eligible patients are those aged 12 and older with AQP4 positivity who have had recent relapses and are planned to receive or are receiving satralizumab for at least 12 months. The lead site is Huashan Hospital in Shanghai, with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody, ≥ 12 years old;
2. EDSS score ≤ 8.5 at baseline;
3. Patients have experienced ≥ 1 relapse of NMOSD in the last 12 months or ≥ 2 relapses in the last 24 months;
4. Patients should have received or be anticipated to receive satralizumab treatment for at least 12 months;
5. 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).

Exclusion Criteria:

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Where it's running

• Huashan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Chao Quan, Doctor — Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China
• Study coordinator: Chao Quan, Doctor
• Email: chao_quan@fudan.edu.cn
• Phone: +8613651957283

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.