Neuromyelitis Optica Spectrum Disorders (NMOSD)
Conditions
Keywords
NMOSD, Satralizumab
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.
Interventions
DRUGSatralizumab
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.
Sponsors
Junwei Hao, MD
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
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EDSS | 24 weeks | Change in EDSS score between at baseline and at 6 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EDSS | 12 weeks | Change in EDSS score between at baseline and at 3 months of treatment |
| mRS | 12 weeks | Changes in mRS between at baseline and at 3 months of treatment |
| EQ-5D | 12 weeks | Changes in EQ-5D between at baseline and at 3 months of treatment |
| ADL score | 12 weeks | Changes in ADL score between at baseline and at 3 months of treatment |
| relapse | 24 weeks | Relapse events occurring within 6 months of treatment |
Countries
China
Contacts
CONTACTXixi Yang, MD, PhD
CONTACTZheng Liu, MD, PhD
PRINCIPAL_INVESTIGATORJunwei Hao, MD, PhD
Xuanwu Hospital Department of Neurology
Outcome results
None listed