Neuromyelitis Optica Spectrum Disorder Clinical Trial
— CAMPUSOfficial 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
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.
Status | Not yet recruiting |
Enrollment | 144 |
Est. completion date | December 31, 2024 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Third Affiliated Hospital, Sun Yat-Sen University | Guangdong 999 Brain Hospital, Zhongshan Ophthalmic Center, Sun Yat-sen University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) |
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