drugset / Trial / NCT01727193

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

NCT01727193

Phase 3 Completed 290 enrolled First Affiliated Hospital, Sun Yat-Sen University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-09
Primary completion
2021-10-18
Completion
2021-11-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azathioprine Small molecule 2 mg/kg
Comparator Leflunomide Small molecule 10 mg
Comparator Leflunomide Small molecule 20 mg

Indications