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

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 2

Conditions: Neuromyelitis Optica Spectrum Disorder

Treatments: Device: blood purification equipment

Study type: Interventional

Funder types: Other

Identifiers

NCT04064944

20190705

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Immunoadsorption group

Experimental group

Description:

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

Treatment:

Device: blood purification equipment

Plasma exchange group

Experimental group

Description:

patients' blood purification treatment protocal is Plasma exchange method.

Treatment:

Device: blood purification equipment