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The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy

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 November 2012 by First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Liu Weibin, First Affiliated Hospital, Sun Yat-Sen University Identifier:
First received: November 8, 2012
Last updated: November 16, 2012
Last verified: November 2012
This is a randomized controlled clinical study. The investigators screen of eligible patients, randomized divide into the following two groups: corticosteroids + azathioprine group, corticosteroids + leflunomide group. The investigators treat the enrolled patients, estimate efficacy and observed the side effects according to the requirements of program. The investigators establish a clinical database for recording patients date and statistical analysis. Evaluation of short-term and long-term efficacy of thymectomized myasthenia gravis patients in the different group prove that what kind of treatment can improve the cure rate. The investigators will evaluate the acute toxicity (gastrointestinal side effects, liver and kidney dysfunction) and long-term toxicity (immune dysfunction, gonadal suppression) when the investigators apply these therapy in the treatment of different clinical types of MG.

Condition Intervention Phase
Myasthenia Gravis
Drug: Azathioprine
Drug: Leflunomide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • the percent of achieving good response [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • level of the AChR-Ab [ Time Frame: 48 weeks ]

Estimated Enrollment: 158
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Azathioprine
cholinesterase inhibitors+Glucocorticoid +Azathioprine
Drug: Azathioprine
The basic therapy of each group is cholinesterase inhibitors (pyridostigmine 36mg / kg / d). Group 1 glucocorticoid + Azathioprine: Glucocorticoid (0.25mg/kg/d )plus Azathioprine at a starting dose of 50mg/d for 14 days, then increase up to 2mg/kg in 2 weeks.If no adverse events occurred , maintain the dose until 48 weeks.
Active Comparator: Leflunomide
cholinesterase inhibitors+glucocorticoid+Leflunomide
Drug: Leflunomide
The basic therapy of each group is cholinesterase inhibitors (pyridostigmine 36mg / kg / d). Group 2 glucocorticoid + Leflunomide: Glucocorticoid (0.25mg/kg/d )plus Leflunomide 20mg/d for adult, 10mg/d for child. if no adverse events occurred , maintain the dose until 48 weeks.


Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 12 to 65 years;
  2. Myasthenia gravis:

    1. Patients who are diagnosed as generalized or ocular myasthenia gravis
    2. have experienced extended thymectomy (including thymic hyperplasia and thymoma), no significant complications in 6 months after operation , and does not received any immunosuppressants or glucocorticoids treatments.
    3. do not applied in plasmapheresis or immunoglobulins treatment during 3 months .
    4. women of child-bearing period do not have a plan of pregnant for at least 3 year.
    5. Written consent of the patient, after informing

Exclusion Criteria:

  1. The liver , kidney function or glycometabolism is abnormal
  2. Seriously complications, such as infection or symptom in central nervous system,
  3. The patients who suffering from malignancy or a history of malignancy, a variety of sexually transmitted diseases and HIV infection, tuberculosis infection, and other condition which need to prohibit the use of immunosuppressive patients.
  4. Be allergic to leflunomide, azathioprine
  5. Pregnant or suckling period woman
  6. Accompanied with mental disorders and have difficult to communication
  7. Experienced myasthenia crisis in 3 months.
  8. suffering from clear cardiopulmonary functional and brain abnormalities
  9. Have a history of refractory hypertension or peptic ulcer .
  10. One of the white blood cells, hemoglobin, and platelet count obvious abnormalities
  Contacts and Locations
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Please refer to this study by its identifier: NCT01727193

Contact: Liu Wei bin, dean 086-020-87755766 ext 8281

China, Guangdong
the first affiliated hospital,SUN YAT-SEN UNIVERSITY Recruiting
GuangZhou, Guangdong, China, 510000
Contact: Liu Wei bin, dean    086-020-887755766 ext 8281   
Principal Investigator: Liu Wei bin, dean         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
  More Information

Responsible Party: Liu Weibin, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University Identifier: NCT01727193     History of Changes
Other Study ID Numbers: ZS-LEF
Study First Received: November 8, 2012
Last Updated: November 16, 2012

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
myasthenia gravis

Additional relevant MeSH terms:
Myasthenia Gravis
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents processed this record on May 22, 2017