BLAZE-Limiting Approach in NMOSD

NCT06888622 | Completed

• 2 other identifiers: KY2025-062MR-31-22-008563; ChiCTR2000030
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational cohort study based on data from the hospital-based NMOSD registry (Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025, 26 consecutive patients with AQP4-IgG-positive NMOSD received eculizumab, and 9 of them were included in this study.

Conditions

Neuromyelitis Optica Spectrum Disorders (NMOSD)

Keywords

NMOSD; eculizumab; AQP4-ab; Neuromyelitis Optica Spectrum Disorders

Outcome Measures

Primary Outcomes (2)

• The change in disability status measured by the MRC scale score

  Measured by the MRC scale score for patients with LETM

  0, 1, 2, 3, 4, 8 weeks

• The change in disability status

  Measured by the best corrected visual acuity (BCVA)

  0, 1, 2, 3, 4, 8 weeks

Secondary Outcomes (4)

• Incidence of AEs and SAEs during eculizumab treatment

  1, 2, 3, 4, 8 weeks

• The Change in Expanded Disability Status Scale (EDSS) scores

  0, 1, 2, 3, 4, 8 weeks

• The Change in Opticospinal Impairment Scale (OSIS) scores

  0, 1, 2, 3, 4, 8 weeks

• The change in Visual Functional System Score (VFSS)

  0, 1, 2, 3, 4, 8 weeks

Other Outcomes (2)

• The changes of serological biomarkers (sGFAP and sNfL)

  0, 2, 4, 8 weeks

• The changes of OCT measurements (pRNFL and mGCIPL).

  0, 1, 2, 3, 4, 8 weeks

Study Arms (1)

Eculizumab treatment group

Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks

Drug: Eculizumab administration

Interventions

Eculizumab administration DRUG

Eculizumab was administered intravenously at a dosage of 900 mg weekly for four consecutive weeks

Eculizumab treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is an observational cohort study based on data from the prospectively followed NMOSD cohort of the hospital-based registry (The Chinese Medical Research Registration Number MR-31-22-008563; ChiCTR2000030651). Between October 2023 (when eculizumab was approved for NMOSD in China) and February 2025 consecutive patients with AQP4-IgG-positive NMOSD received eculizumab were enrolled.

You may qualify if:

• (1)Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody; (2) Age ≥ 18 years; (3) Received eculizumab during an acute phase of NMOSD, defined as within 30 days of attack onset； (4) Adherence to an 8-week follow-up from eculizumab initiation.

You may not qualify if:

• Patients with unresolved Neisseria meningitidis infection or severe infections that preclude the use of immunotherapy;
• Patients with severe comorbidities (such as heart failure, respiratory failure, severe hepatic or renal dysfunction, etc.);
• Patients with incomplete records of clinical symptoms and signs, as well as insufficient data on serum marker tests in their medical records.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Chao Quan, Doctor

  Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 21, 2025
• Study Start: October 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 3, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)