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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
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromyelitis Optica Spectrum Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    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
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    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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