Clinical trial NCT01727193: The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy
Official title: The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myasthenia Gravis
Keywords: myasthenia gravis
leflunomide
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 290
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: the percent of achieving good response
timeFrame: 144 weeks
Secondary outcomes:
measure: The changes of the disease severity and the antibody titer during the follow-up
timeFrame: 144 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, SUN YAT-SEN UNIVERSITY
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Weibin Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: