Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

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Neuromyelitis optica (NMO) is an autoimmune inflammatory demyelinating disease of the central nervous system that leads to blindness and paralysis. Since disability accrues incrementally related to attacks, attack prevention with immunosuppressive therapy is the mainstay of preventing disability. However, there is no standard immunosuppressive treatment strategy for NMO relapse prevention. In a previous study, the investigators provided evidence supporting the use of azathioprine plus a low dose corticosteroid as an effective strategy which is associated with a reduction in the risk of relapse in Chinese patients with NMO, but azathioprine has bone marrow suppression and other side effects. Mycophenolate mofetil (MMF) is a new immunosuppressant with rapid onset, fewer side effects and other advantages. In recent years, MMF has been used in different immune-related neurological diseases; some literature shown the possible efficacy of MMF in NMO treatment.

In this research, a multi-center (Third Affiliated Hospital of Sun Yat-sen University, Zhongshan Ophthalmic Centre of Sun Yat-sen University, Nangfang Hospital of Southern Medical University) study will carry out to evaluate the efficacy and safety of mycophenolate mofetil therapy in NMO spectrum disorders.

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Detailed Description

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Conditions

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Neuromyelitis Optica Spectrum Disorders Mycophenolate Mofetil Efficacy and Safety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mycophenolate mofetil plus prednisone

Mycophenolate mofetil 500mg Bid and prednisone 10mg Qd

Group Type EXPERIMENTAL

Mycophenolate mofetil

Intervention Type DRUG

Mycophenolate mofetil 500mg Bid

Prednisone

Intervention Type DRUG

prednisone 10mg Qd

Interventions

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Mycophenolate mofetil

Mycophenolate mofetil 500mg Bid

Intervention Type DRUG

Prednisone

prednisone 10mg Qd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meet the 2006 Wingerchuk diagnostic criteria;
* NMO-immunoglobulin G seropositive;
* Between 18 to 65 years old;
* Relapse: more than 2 relapses in recent 2 years; more than 1 relapses in recent 1 years;
* Expanded disability status scale: expanded disability status scale≤7.0, and visual acuity ≥20 / 100 at least in one eye
* Understand the purpose and procedures of this study, and written informed consent is obtained.

Exclusion Criteria

* Using immunosuppressive agents and other drugs affect evaluation, and drug withdrawal less than 3 months;
* Patients with any of the following diseases: transaminases elevation exceed 2 times of the normal upper limit; white blood cell \<4 × 109 / L, Hemoglobin \<80g / L, platelet \<100 × 109 / L;
* With serious cardiovascular, liver, kidneys and other vital organs and blood, endocrine system diseases, cancer history;
* With immunodeficiency, uncontrolled infection and active gastrointestinal diseases (such as gastric ulcer, etc.);
* Pregnancy, breast-feeding women and male or female who plans to conceive recently;
* Allergy to mycophenolate mofetil and prednisone.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No