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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuromyelitis Optica Spectrum Disorder
• Intervention / Treatment: Device: blood purification equipment

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wei Qiu; Phone Number: 0086- 15899968330; Email: qw9406@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of follow-up results of EDSS scores	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	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	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)	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	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	the next 1 day, 1 week, 2 weeks, 3 months after the last treatment vs. baseline (that of the time before first treatment)

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Zhongshan Ophthalmic Center, Sun Yat-sen University; Guangdong 999 Brain Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (ACTUAL): August 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: refractory; immunoadsorption; Neuromyelitis Optica Spectrum Disorder; plasma exchange; acute attack
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Disease; Neuromyelitis Optica
• Other Study ID Numbers: 20190705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No