Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders

Phase 2

Not yet recruiting

• Conditions: Neuromyelitis Optica Spectrum Disorder
• Interventions: Device: blood purification equipment

• Registration Number: NCT04064944
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-21
• Last Update Submitted: 2019-08-21
• Study First Posted: 2019-08-22
• Last Update Posted: 2019-08-22
• Study Start: 2019-09-01
• Primary Completion: 2023-08-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Patients should meet the 2015 International NMOSD with acute attacks diagnostic criteria (including first episodes and recurrences)
2. 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
3. Serum AQP4-IgG positive (CBA test)

Exclusion Criteria

1. Weight <25Kg
2. Nursing or pregnant women
3. Unable to establish a peripheral or central vascular access
4. The use of rituximab and gamma-ball shocks within 3 months prior to enrollment
5. Using immunoadsorption and/or plasma exchange therapy within 3 months before enrollment
6. ACEI drugs must be taken within 1 week before the first treatment and during treatment and cannot be stopped

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasma exchange group	blood purification equipment	patients' blood purification treatment protocal is Plasma exchange method.
Immunoadsorption group	blood purification equipment	patients' blood purification treatment protocal is Protain A Immunoadsorption method.

Primary Outcome Measures

Name	Time	Method
Changes in EDSS scores	4 weeks after the last treatment vs.baseline ( first treatment)	Changes in EDSS scores of 4 weeks after the last treatment of plasma exchange or immunoadsorption compared with the first treatment

Secondary Outcome Measures

Name	Time	Method
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)	Comparation of the changes in LogMAR of the next day, 1 week, 2 weeks, 3 months after the last plasmapheresis or immunoadsorption treatment vs. that before the first treatment (NMO patients)
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)	Comparation of the changes in EDSS scores of the next day, 1 week, 2 weeks, 3 months after the last plasmapheresis or immunoadsorption treatment vs. that before the 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)	Comparation of the changes in AQP4-IgG level of the next day, 1 week, 2 weeks, 3 months after the last plasmapheresis or immunoadsorption treatment vs. that before the first treatment