A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatm… (NCT07762872) | Clinical Trial Compass
RecruitingNot Applicable
A Multicenter Prospective Real-World Effectiveness and Safety of Satralizumab in the Early Treatment of Attacks in NMOSD
China50 participantsStarted 2026-07-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.