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

ConditionNeuromyelitis Optica Spectrum Disorders (NMOSD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJunwei Hao, MD

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Satralizumab Treatment Group1 intervention

Trial outcomes

Primary outcomes

1

EDSS

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

Time frame
24 weeks

Secondary outcomes

1

EDSS

Change in EDSS score between at baseline and at 3 months of treatment

Time frame
12 weeks
2

mRS

Changes in mRS between at baseline and at 3 months of treatment

Time frame
12 weeks
3

EQ-5D

Changes in EQ-5D between at baseline and at 3 months of treatment

Time frame
12 weeks
4

ADL score

Changes in ADL score between at baseline and at 3 months of treatment

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Junwei Hao, MD

Lead sponsor

Xuanwu Hospital, Beijing

Sponsor institution

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

Source ClinicalTrials.gov
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