The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy
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|ClinicalTrials.gov Identifier: NCT01727193|
Recruitment Status : Unknown
Verified September 2019 by Liu Weibin, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Recruiting
First Posted : November 15, 2012
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Myasthenia Gravis||Drug: Azathioprine Drug: Leflunomide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
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.
- the percent of achieving good response [ Time Frame: 48 weeks ]
- level of the acetylcholine receptor antibody [ Time Frame: 48 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727193
|Contact: Liu Wei bin, dean||086-020-87755766 ext firstname.lastname@example.org|
|the first affiliated hospital,SUN YAT-SEN UNIVERSITY||Recruiting|
|GuangZhou, Guangdong, China, 510000|
|Contact: Liu Wei bin, dean 086-020-887755766 ext 8281 email@example.com|
|Principal Investigator: Liu Wei bin, dean|