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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2022
• Main ID: NCT01727193
• Date of registration: 08/11/2012
• Prospective Registration: No
• Primary sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Public title: The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy
• Scientific title: The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy
• Date of first enrolment: September 2012
• Target sample size: 290
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01727193
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Weibin Liu, Doctor
• Affiliation: First Affiliated Hospital, Sun Yat-Sen University

Key inclusion & exclusion 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 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 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



Age minimum: 12 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Myasthenia Gravis

Intervention(s)

Drug: Leflunomide

Drug: Azathioprine

Primary Outcome(s)

the percent of achieving good response [Time Frame: 144 weeks]

Secondary Outcome(s)

The changes of the disease severity and the antibody titer during the follow-up [Time Frame: 144 weeks]

Secondary ID(s)

ZS-LEF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors