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Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients

Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02809079
Acronym
MONICA
Enrollment
100
Registered
2016-06-22
Start date
2016-01-31
Completion date
2017-12-31
Last updated
2016-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy and Safety, Mycophenolate Mofetil, Neuromyelitis Optica Spectrum Disorders

Brief summary

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.

Interventions

DRUGMycophenolate mofetil

Mycophenolate mofetil 500mg Bid

DRUGPrednisone

prednisone 10mg Qd

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
CollaboratorOTHER
Southern Medical University, China
CollaboratorOTHER
Third Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Annualized relapse rate day 360day 360 after staring treatmentPatients come back for follow-up visit on day 360 after staring treatment, and annualized relapse rate was evaluated.

Secondary

MeasureTime frameDescription
expanded disability status scaleday 1, 14, 30, 90, 180, 270, 360 after staring treatmentPatients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, and expanded disability status scale was evaluated.
Hauser scaleday 1, 14, 30, 90, 180, 270, 360 after staring treatmentPatients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, and Hauser scale was evaluated.
vision scaleday 1, 14, 30, 90, 180, 270, 360 after staring treatmentPatients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, and vision scale was evaluated.
Lesions in brain and spinal cordday 1, 14, 30, 90, 180, 270, 360 after staring treatmentPatients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, lesions in brain and spinal cord were evaluated by MRI.
Annualized relapse rateday 1, 14, 30, 90, 180, 270 after staring treatmentPatients come back for follow-up visit on day 1, 14, 30, 90, 180, 270 after staring treatment, and annualized relapse rate was evaluated.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026