Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients (MONICA)
Primary Purpose
Neuromyelitis Optica Spectrum Disorders, Mycophenolate Mofetil, Efficacy and Safety
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mycophenolate mofetil
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Neuromyelitis Optica Spectrum Disorders
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mycophenolate mofetil plus prednisone
Arm Description
Mycophenolate mofetil 500mg Bid and prednisone 10mg Qd
Outcomes
Primary Outcome Measures
Annualized relapse rate day 360
Patients come back for follow-up visit on day 360 after staring treatment, and annualized relapse rate was evaluated.
Secondary Outcome Measures
expanded disability status scale
Patients 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 scale
Patients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, and Hauser scale was evaluated.
vision scale
Patients 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 cord
Patients 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 rate
Patients come back for follow-up visit on day 1, 14, 30, 90, 180, 270 after staring treatment, and annualized relapse rate was evaluated.
Full Information
NCT ID
NCT02809079
First Posted
June 12, 2016
Last Updated
June 19, 2016
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University, Southern Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02809079
Brief Title
Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients
Acronym
MONICA
Official Title
Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University, Southern Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromyelitis Optica Spectrum Disorders, Mycophenolate Mofetil, Efficacy and Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mycophenolate mofetil plus prednisone
Arm Type
Experimental
Arm Description
Mycophenolate mofetil 500mg Bid and prednisone 10mg Qd
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Intervention Description
Mycophenolate mofetil 500mg Bid
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
prednisone 10mg Qd
Primary Outcome Measure Information:
Title
Annualized relapse rate day 360
Description
Patients come back for follow-up visit on day 360 after staring treatment, and annualized relapse rate was evaluated.
Time Frame
day 360 after staring treatment
Secondary Outcome Measure Information:
Title
expanded disability status scale
Description
Patients 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.
Time Frame
day 1, 14, 30, 90, 180, 270, 360 after staring treatment
Title
Hauser scale
Description
Patients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, and Hauser scale was evaluated.
Time Frame
day 1, 14, 30, 90, 180, 270, 360 after staring treatment
Title
vision scale
Description
Patients come back for follow-up visit on day 1, 14, 30, 90, 180, 270, 360 after staring treatment, and vision scale was evaluated.
Time Frame
day 1, 14, 30, 90, 180, 270, 360 after staring treatment
Title
Lesions in brain and spinal cord
Description
Patients 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.
Time Frame
day 1, 14, 30, 90, 180, 270, 360 after staring treatment
Title
Annualized relapse rate
Description
Patients come back for follow-up visit on day 1, 14, 30, 90, 180, 270 after staring treatment, and annualized relapse rate was evaluated.
Time Frame
day 1, 14, 30, 90, 180, 270 after staring treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Qiu, Medical PhD
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
share by publications and meetings
Citations:
PubMed Identifier
16638802
Citation
Falcini F, Trapani S, Ricci L, Resti M, Simonini G, de Martino M. Sustained improvement of a girl affected with Devic's disease over 2 years of mycophenolate mofetil treatment. Rheumatology (Oxford). 2006 Jul;45(7):913-5. doi: 10.1093/rheumatology/kei263. Epub 2006 Apr 25. No abstract available.
Results Reference
result
PubMed Identifier
25199960
Citation
Huh SY, Kim SH, Hyun JW, Joung AR, Park MS, Kim BJ, Kim HJ. Mycophenolate mofetil in the treatment of neuromyelitis optica spectrum disorder. JAMA Neurol. 2014 Nov;71(11):1372-8. doi: 10.1001/jamaneurol.2014.2057.
Results Reference
result
PubMed Identifier
19752302
Citation
Jacob A, Matiello M, Weinshenker BG, Wingerchuk DM, Lucchinetti C, Shuster E, Carter J, Keegan BM, Kantarci OH, Pittock SJ. Treatment of neuromyelitis optica with mycophenolate mofetil: retrospective analysis of 24 patients. Arch Neurol. 2009 Sep;66(9):1128-33. doi: 10.1001/archneurol.2009.175.
Results Reference
result
PubMed Identifier
30258442
Citation
Huang Q, Wang J, Zhou Y, Yang H, Wang Z, Yan Z, Long Y, Yin J, Feng H, Li C, Lu Z, Hu X, Qiu W. Low-Dose Mycophenolate Mofetil for Treatment of Neuromyelitis Optica Spectrum Disorders: A Prospective Multicenter Study in South China. Front Immunol. 2018 Sep 11;9:2066. doi: 10.3389/fimmu.2018.02066. eCollection 2018.
Results Reference
derived
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Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients
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