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

Last updated: April 6, 2022
Sponsor: First Affiliated Hospital, Sun Yat-Sen University
Overall Status: Completed

Phase

3

Condition

Sarcopenia

Neuropathy

Polymyositis (Inflammatory Muscle Disease)

Treatment

N/A

Clinical Study ID

NCT01727193
ZS-LEF
  • Ages 12-65
  • All Genders

Study Summary

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 myasthenia gravis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 12 to 65 years；
  2. Myasthenia gravis:
  3. Patients who are diagnosed as generalized or ocular myasthenia gravis
  4. have experienced extended thymectomy (including thymic hyperplasia and thymoma)，no significant complications in 6 months after operation , and does not receivedany immunosuppressants or glucocorticoids treatments.
  5. do not applied in plasmapheresis or immunoglobulins treatment during 3 months .
  6. women of child-bearing period do not have a plan of pregnant for at least 3 year.
  7. Written consent of the patient, after informing

Exclusion

Exclusion Criteria:

  1. The liver , kidney or glycometabolic function 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 ofsexually transmitted diseases and HIV infection, tuberculosis infection, and othercondition 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

Study Design

Total Participants: 290
Study Start date:
September 01, 2012
Estimated Completion Date:
November 18, 2021

Connect with a study center

  • The First Affiliated Hospital, SUN YAT-SEN UNIVERSITY

    Guangzhou, Guangdong 510080
    China

    Site Not Available

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