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Trial record 15 of 54 for:    Devic syndrome

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

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ClinicalTrials.gov Identifier: NCT04064944
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangdong 999 Brain Hospital
Information provided by (Responsible Party):
Wei Qiu, 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.


Condition or disease Intervention/treatment Phase
Neuromyelitis Optica Spectrum Disorder Device: blood purification equipment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : December 31, 2024


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.




Primary Outcome Measures :
  1. Changes in EDSS scores [ Time Frame: 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 :
  1. Comparison of follow-up results of EDSS scores [ Time Frame: 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

  2. Comparison of follow-up results of LogMAR [ Time Frame: 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)

  3. Comparison of follow-up results of AQP4-IgG level [ Time Frame: 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



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064944


Contacts
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Contact: Wei Qiu 0086- 15899968330 qw9406@gmail.com

Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangdong 999 Brain Hospital

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Responsible Party: Wei Qiu, professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04064944     History of Changes
Other Study ID Numbers: 20190705
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wei Qiu, Third Affiliated Hospital, Sun Yat-Sen University:
Neuromyelitis Optica Spectrum Disorder
immunoadsorption
plasma exchange
acute attack
refractory
Additional relevant MeSH terms:
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Neuromyelitis Optica
Disease
Pathologic Processes
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases