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

This study is currently recruiting participants.
Verified November 2012 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Liu Weibin, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01727193
First received: November 8, 2012
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • level of the AChR-Ab [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727193

Contacts
Contact: Liu Wei bin, dean 086-020-87755766 ext 8281 ranliuz@163.com

Locations
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     ranliuz@163.com    
Principal Investigator: Liu Wei bin, dean            
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Myasthenia Gravis
Muscle Weakness
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Cholinesterase Inhibitors
 Azathioprine
Leflunomide
Glucocorticoids
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013