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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Qualitix Clinical Research Co., Ltd..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00997412
First Posted: October 19, 2009
Last Update Posted: October 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Qualitix Clinical Research Co., Ltd.
  Purpose
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.

Condition Intervention
Myasthenia Gravis Drug: Mycophenolic acid Drug: AZA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Double-dummy Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis

Resource links provided by NLM:


Further study details as provided by Qualitix Clinical Research Co., Ltd.:

Primary Outcome Measures:
  • The ratio of two arms patients achieve minimal manifestation (MM, i.e. complete remission) [ Time Frame: One year after treatment ]

Secondary Outcome Measures:
  • Osserman clinical classification [ Time Frame: One year after treatment ]
  • Myasthenia gravis (MG) score [ Time Frame: One year after treatment ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MA
MA group: 1 tablet AZA placebo and 4 tablets MA (180mg/tab,720 mg/day) twice daily
Drug: Mycophenolic acid
180 mg/tablet, 4 tablets twice daily
Active Comparator: AZA
AZA group: 1 tablet AZA (50mg/tab) and 4 tablets MA placebo twice daily
Drug: AZA
1 tablet AZA (50 mg/tab) and 4 tablets MA placebo twice daily

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997412


Sponsors and Collaborators
Qualitix Clinical Research Co., Ltd.
Investigators
Principal Investigator: Jiann-Horng Yeh, M.D. Shin Kong Wu Ho-Su Memorial Hospital
  More Information

Responsible Party: Jiann-Horng Yeh / M.D., Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT00997412     History of Changes
Other Study ID Numbers: CERL080ATW07T
First Submitted: October 16, 2009
First Posted: October 19, 2009
Last Update Posted: October 19, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Azathioprine
Mycophenolate mofetil
Mycophenolic Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors