Efficacy and Safety of Belimumab in Neuromyelitis Optica Spectrum Disorders

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    12
  • sponsor
    Tianjin Medical University General Hospital
Updated on 28 May 2022
Accepts healthy volunteers

Summary

Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Belimumab (Benlysta ®) is a human immunoglobulin G1λ monoclonal antibody that inhibits B-cell survival and differentiation by neutralizing soluble B lymphocyte stimulator. Belimumab may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clincial trials may be needed to observe its efficacy and safety.

Description

The investigators primarily aim to observe the time to first relapse from initiation of belimumab treatment.

The secondary outcomes are to determine: The safety profile of belimumab in participants with NMO and whether belimumab improves Expanded Disability Status Scale (EDSS), et al.

Details
Condition NMO Spectrum Disorder
Treatment belimumab
Clinical Study IdentifierNCT05154734
SponsorTianjin Medical University General Hospital
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female patients ≥ 18 years old
Diagnosis of NMO or NMO spectrum disorder according to the 2015 International diagnostic criteria for neuromyelitis optic
Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months
EDSS <= 6.0
Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria

Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, Hepatitis viruses, Syphilis, etc)
Participation in another interventional trial within the last 3 months
Tumor disease currently or within last 5 years
Pregnant, breastfeeding, or child-bearing potential during the course of the study
Clinically relevant heart, liver, kidney or bone marrow function disorder
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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