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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 because the information has not been verified recently.
Verified October 2009 by Qualitix Clinical Research Co., Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Qualitix Clinical Research Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00997412
First received: October 16, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 16, 2009
Last Updated: October 16, 2009
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Myasthenia Gravis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Immune System Diseases
Nervous System Diseases
Neuromuscular Diseases
Neuromuscular Junction Diseases
Azathioprine
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014