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Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis (Myfortic)

Primary Purpose

Myasthenia Gravis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mycophenolic acid
AZA
Sponsored by
Qualitix Clinical Research Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myasthenia Gravis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female age between 20-70 (including 20 and 70 years old).
  • Osserman II and III Myasthenia Gravis.
  • Positive serum anti-acetylcholine receptor antibodies.
  • Poor control of disease with daily dose of prednisone ≥ 30 mg or 0.5 mg/kg at 3 months before enrollment.
  • Without immunosuppressive therapy other than steroid.

Exclusion Criteria:

  • Ocular MG or minimal clinical syndrome that would not require the therapy of steroids.
  • Negative serum anti-acetylcholine receptor antibodies.
  • Use immunosuppressants other than steroids in the preceding year.
  • Previous use other investigational medication within 3 months or current participate other clinical study.
  • Poor renal function: serum creatinine > 3.0 mg/dl or estimated creatinine clearance < 30 ml/min
  • Females who are pregnancy or breast-feeding.
  • Recent history, within 5 years, of malignancy
  • Unwilling or unable to participate the necessary continuous visits and examinations.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MA

    AZA

    Arm Description

    MA group: 1 tablet AZA placebo and 4 tablets MA (180mg/tab,720 mg/day) twice daily

    AZA group: 1 tablet AZA (50mg/tab) and 4 tablets MA placebo twice daily

    Outcomes

    Primary Outcome Measures

    The ratio of two arms patients achieve minimal manifestation (MM, i.e. complete remission)

    Secondary Outcome Measures

    Osserman clinical classification
    Myasthenia gravis (MG) score

    Full Information

    First Posted
    October 16, 2009
    Last Updated
    October 16, 2009
    Sponsor
    Qualitix Clinical Research Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00997412
    Brief Title
    Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis
    Acronym
    Myfortic
    Official Title
    Randomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2009 (undefined)
    Primary Completion Date
    May 2011 (Anticipated)
    Study Completion Date
    May 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Qualitix Clinical Research Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an randomized, double-blind, double-dummy trial, and the objective is to compare the efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive drugs, in myasthenia gravis patients. This prospective study will enroll 40 myasthenia gravis (MG) patients who are poor controlled under prior steroid therapy. All subjects should be randomly assigned to MA group and AZA group that will receive routine pyridostigmine and prednisolone in combination with MA or AZA.
    Detailed Description
    This will be a double-dummy study to keep the blinded quality. MA group: 1 tablet AZA placebo and 4 tables MA (180 mg/tab,720 mg/day) twice daily. AZA group: 1 tablet AZA (50mg/tab) and 4 tables MA placebo twice daily. When patients achieve minimal manifestation (MM, i.e. complete remission), which lead to normal daily routine, the dose of pyridostigmine should reduce to 240 mg/day (4 tablets) or less. The dose of steroid should be stepped down by 10 mg qod (every other day) for every 2 weeks until the dose achieves 40 mg qod. After that, the dose should be stepped down by 5 mg qod for every month. When disease progresses and is no longer maintaining minimal manifestation, the dose of steroid will be stepped up by 10 mg qod for every 2 weeks until achieve clinical stable remission. The taper rule of steroid could start again 1 month after stabilization. Every patient will be treated for 1 year. If the patient could not achieve MM within 1 year, the blind of individual patient will be opened and the patients will be crossed over to another medical treatment. The efficacy and safety of second medication will be observed openly until the end of study. When the muscle weakness worsens under established study schedule, plasmapheresis could be conducted to improve the condition rapidly.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myasthenia Gravis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MA
    Arm Type
    Experimental
    Arm Description
    MA group: 1 tablet AZA placebo and 4 tablets MA (180mg/tab,720 mg/day) twice daily
    Arm Title
    AZA
    Arm Type
    Active Comparator
    Arm Description
    AZA group: 1 tablet AZA (50mg/tab) and 4 tablets MA placebo twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Mycophenolic acid
    Intervention Description
    180 mg/tablet, 4 tablets twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    AZA
    Intervention Description
    1 tablet AZA (50 mg/tab) and 4 tablets MA placebo twice daily
    Primary Outcome Measure Information:
    Title
    The ratio of two arms patients achieve minimal manifestation (MM, i.e. complete remission)
    Time Frame
    One year after treatment
    Secondary Outcome Measure Information:
    Title
    Osserman clinical classification
    Time Frame
    One year after treatment
    Title
    Myasthenia gravis (MG) score
    Time Frame
    One year after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female age between 20-70 (including 20 and 70 years old). Osserman II and III Myasthenia Gravis. Positive serum anti-acetylcholine receptor antibodies. Poor control of disease with daily dose of prednisone ≥ 30 mg or 0.5 mg/kg at 3 months before enrollment. Without immunosuppressive therapy other than steroid. Exclusion Criteria: Ocular MG or minimal clinical syndrome that would not require the therapy of steroids. Negative serum anti-acetylcholine receptor antibodies. Use immunosuppressants other than steroids in the preceding year. Previous use other investigational medication within 3 months or current participate other clinical study. Poor renal function: serum creatinine > 3.0 mg/dl or estimated creatinine clearance < 30 ml/min Females who are pregnancy or breast-feeding. Recent history, within 5 years, of malignancy Unwilling or unable to participate the necessary continuous visits and examinations.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiann-Horng Yeh, M.D.
    Organizational Affiliation
    Shin Kong Wu Ho-Su Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis

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