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
Information provided by (Responsible Party):
Liu Weibin, First Affiliated Hospital, Sun Yat-Sen University
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
Active Comparator: Azathioprine
cholinesterase inhibitors+Glucocorticoid +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
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 12 to 65 years；
- Patients who are diagnosed as generalized or ocular myasthenia gravis
- 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.
- do not applied in plasmapheresis or immunoglobulins treatment during 3 months .
- women of child-bearing period do not have a plan of pregnant for at least 3 year.
- Written consent of the patient, after informing
- The liver , kidney function or glycometabolism is abnormal
- Seriously complications, such as infection or symptom in central nervous system,
- 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.
- Be allergic to leflunomide, azathioprine
- Pregnant or suckling period woman
- Accompanied with mental disorders and have difficult to communication
- Experienced myasthenia crisis in 3 months.
- suffering from clear cardiopulmonary functional and brain abnormalities
- Have a history of refractory hypertension or peptic ulcer .
- One of the white blood cells, hemoglobin, and platelet count obvious abnormalities
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727193
|the first affiliated hospital,SUN YAT-SEN UNIVERSITY
|GuangZhou, Guangdong, China, 510000 |
|Contact: Liu Wei bin, dean 086-020-887755766 ext 8281 email@example.com |
|Principal Investigator: Liu Wei bin, dean |
First Affiliated Hospital, Sun Yat-Sen University
No publications provided
||Liu Weibin, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 8, 2012
||November 16, 2012
||China: Ethics Committee
Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
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