Back to resultsThe Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy
Primary Purpose
Myasthenia Gravis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Azathioprine
Leflunomide
Sponsored by
About this trial
This is an interventional treatment trial for Myasthenia Gravis focused on measuring myasthenia gravis, leflunomide
Eligibility Criteria
Inclusion Criteria:
- 12 to 65 years；
Myasthenia gravis:
- 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
Exclusion Criteria:
- The liver , kidney or glycometabolic function 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
Sites / Locations
- The First Affiliated Hospital, SUN YAT-SEN UNIVERSITY
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Azathioprine
Leflunomide
Arm Description
cholinesterase inhibitors+Glucocorticoid +Azathioprine
cholinesterase inhibitors+glucocorticoid+Leflunomide
Outcomes
Primary Outcome Measures
the percent of achieving good response
Pharmacologic Remission (PR) was the primary efficacy endpoint observed. Record the time the patient appears from the time of medication to the time of PR, and calculate the percentage of PR patients in each arm. Criteria for PR: The patient has had no symptoms or signs of MG for at least 1 year and continues to take some form of therapy for MG. There is no weakness of any muscle on careful examination by someone skilled in the evaluation of neuromuscular disease. Isolated weakness of eyelid closure is accepted. Patients taking cholinesterase inhibitors are excluded from this category because their use suggests the presence of weakness.
Secondary Outcome Measures
The changes of the disease severity and the antibody titer during the follow-up
The magnitude by which QMG or ADL scores are reduced. Total amount of steroid used during the follow-up. Level of the acetylcholine receptor antibody.
Full Information
NCT ID
NCT01727193
First Posted
November 8, 2012
Last Updated
April 6, 2022
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT01727193
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
October 18, 2021 (Actual)
Study Completion Date
November 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis
Keywords
myasthenia gravis, leflunomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azathioprine
Arm Type
Active Comparator
Arm Description
cholinesterase inhibitors+Glucocorticoid +Azathioprine
Arm Title
Leflunomide
Arm Type
Active Comparator
Arm Description
cholinesterase inhibitors+glucocorticoid+Leflunomide
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Intervention Description
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
Intervention Name(s)
Leflunomide
Intervention Description
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.
Primary Outcome Measure Information:
Title
the percent of achieving good response
Description
Pharmacologic Remission (PR) was the primary efficacy endpoint observed. Record the time the patient appears from the time of medication to the time of PR, and calculate the percentage of PR patients in each arm. Criteria for PR: The patient has had no symptoms or signs of MG for at least 1 year and continues to take some form of therapy for MG. There is no weakness of any muscle on careful examination by someone skilled in the evaluation of neuromuscular disease. Isolated weakness of eyelid closure is accepted. Patients taking cholinesterase inhibitors are excluded from this category because their use suggests the presence of weakness.
Time Frame
144 weeks
Secondary Outcome Measure Information:
Title
The changes of the disease severity and the antibody titer during the follow-up
Description
The magnitude by which QMG or ADL scores are reduced. Total amount of steroid used during the follow-up. Level of the acetylcholine receptor antibody.
Time Frame
144 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
12 to 65 years；
Myasthenia gravis:
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
Exclusion Criteria:
The liver , kidney or glycometabolic function 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weibin Liu, Doctor
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, SUN YAT-SEN UNIVERSITY
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of Leflunomide or Azathioprine Therapy in Myasthenia Gravis Patients After Expand Thymectomy
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