Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients (MONICA)

Sun Yat-sen University

Status and phase

Unknown

Phase 4

Conditions

Mycophenolate Mofetil

Efficacy and Safety

Neuromyelitis Optica Spectrum Disorders

Treatments

Drug: Prednisone

Drug: Mycophenolate mofetil

Study type

Interventional

Funder types

Other

Identifiers

NCT02809079

2016017

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.