Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders
CAMPUS
1 other identifier
interventional
144
0 countries
N/A
Brief Summary
Neuromyelitis optica spectrum disorder (NMOSD) is one common demyelinating disease of the central nervous system in young adults, with high rate of disability and recurrence, and poor natural course, which can cause a serious burden on families and society. To today, there is still a lack of prospective, multi-center, large sample clinical trial evidence for the treatment and prognosis of acute attack of NMOSD patients. This study will conduct a prospective, multi-center, single-blind, randomized controlled clinical trial of acute attacked NMOSD patients in China. The researchers plan to collect 144 NMOSD patients with acute attack in three research centers of Guangzhou (the Third Affiliated Hospital of Sun Yat-sen University, the Zhongshan Ophthalmic Center of Sun Yat-sen University, and the Guangdong 999 Brain hospital), to study the safety and efficacy of immunoadsorption therapy. The subjects will be randomized into immunoadsorption group and plasma exchange group, and the following indicators will be evaluated: (1) changes in EDSS scores and visual acuity before and after treatment; (2) changes in AQP4-IgG levels; (3) the safety of immunoadsorption treatment. This study is aimed to determine the efficacy and safety of immunoadsorption therapy for acute attack of refractory NMOSD patients, and to provide more sufficient clinical evidence for the therapy selection for acute phase of NMOSD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2019
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2019
CompletedFirst Posted
Study publicly available on registry
August 22, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedAugust 22, 2019
August 1, 2019
3.9 years
August 20, 2019
August 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in EDSS scores
Changes in EDSS scores of 4 weeks after the last treatment of plasma exchange or immunoadsorption compared with the first treatment
4 weeks after the last treatment vs.baseline ( first treatment)
Secondary Outcomes (3)
Comparison of follow-up results of EDSS scores
the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment)
Comparison of follow-up results of LogMAR
the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment)
Comparison of follow-up results of AQP4-IgG level
the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment)
Study Arms (2)
Immunoadsorption group
EXPERIMENTALpatients' blood purification treatment protocal is Protain A Immunoadsorption method.
Plasma exchange group
EXPERIMENTALpatients' blood purification treatment protocal is Plasma exchange method.
Interventions
The subjects enrolled in this study will undergo blood purification treatment, and will be randomized into either immunoadsorption group or plasma exchange group, and the following indicators will be evaluated: (1) changes in EDSS scores and visual acuity before and after treatment; (2) changes in AQP4-IgG levels; (3) the safety of immunoadsorption treatment.
Eligibility Criteria
You may qualify if:
- Patients should meet the 2015 International NMOSD with acute attacks diagnostic criteria (including first episodes and recurrences)
- When NMOSD Patients with acute attacks undergo a course of hormone shock therapy (5-10g total methylprednisolone), EDSS ≥ 6.0 or visual acuity ≤ 20/200
- Serum AQP4-IgG positive (CBA test)
You may not qualify if:
- Weight \<25Kg
- Nursing or pregnant women
- Unable to establish a peripheral or central vascular access
- The use of rituximab and gamma-ball shocks within 3 months prior to enrollment
- Using immunoadsorption and/or plasma exchange therapy within 3 months before enrollment
- ACEI drugs must be taken within 1 week before the first treatment and during treatment and cannot be stopped
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
August 20, 2019
First Posted
August 22, 2019
Study Start
September 1, 2019
Primary Completion
August 1, 2023
Study Completion
December 31, 2024
Last Updated
August 22, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share