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

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04064944

Collaborator

Zhongshan Ophthalmic Center, Sun Yat-sen University (Other), Guangdong 999 Brain Hospital (Other)

144

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromyelitis Optica Spectrum Disorder	Device: blood purification equipment	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of the Efficacy and Safety of Immunoadsorption and Plasma Exchange for Acute Attack of Refractory Neuromyelitis Optica Spectrum Disorders: a Prospective, Multicenter, Single-blind, Randomized Controlled Clinical Trial

Anticipated Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immunoadsorption group patients' blood purification treatment protocal is Protain A Immunoadsorption method.	Device: blood purification equipment 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.
Experimental: Plasma exchange group patients' blood purification treatment protocal is Plasma exchange method.	Device: blood purification equipment 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.

Arm

Intervention/Treatment

Experimental: Immunoadsorption group

patients' blood purification treatment protocal is Protain A Immunoadsorption method.

Device: blood purification equipment

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.

Experimental: Plasma exchange group

patients' blood purification treatment protocal is Plasma exchange method.

Device: blood purification equipment

Outcome Measures

Primary Outcome Measures

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

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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)

Exclusion Criteria:

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