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

NCT ID: NCT01727193

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2021-11-18

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.

Conditions

Myasthenia Gravis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azathioprine

cholinesterase inhibitors+Glucocorticoid +Azathioprine

Group Type: ACTIVE_COMPARATOR

Azathioprine

Intervention Type: DRUG

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.

Leflunomide

cholinesterase inhibitors+glucocorticoid+Leflunomide

Group Type: ACTIVE_COMPARATOR

Leflunomide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Liu Weibin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weibin Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital, SUN YAT-SEN UNIVERSITY

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ZS-LEF

Identifier Type: -

Identifier Source: org_study_id