Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an randomized, double-blind, double-dummy trial, and the objective is to compare the efficacy and safety of Mycophenolic acid (MA) and Azathioprine (AZA), immunosuppressive drugs, in myasthenia gravis patients. This prospective study will enroll 40 myasthenia gravis (MG) patients who are poor controlled under prior steroid therapy. All subjects should be randomly assigned to MA group and AZA group that will receive routine pyridostigmine and prednisolone in combination with MA or AZA.
This will be a double-dummy study to keep the blinded quality.
MA group: 1 tablet AZA placebo and 4 tables MA (180 mg/tab,720 mg/day) twice daily.
AZA group: 1 tablet AZA (50mg/tab) and 4 tables MA placebo twice daily.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MA | Experimental | MA group: 1 tablet AZA placebo and 4 tablets MA (180mg/tab,720 mg/day) twice daily |
|
| AZA | Active Comparator | AZA group: 1 tablet AZA (50mg/tab) and 4 tablets MA placebo twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolic acid | Drug | 180 mg/tablet, 4 tablets twice daily |
| |
| AZA |
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of two arms patients achieve minimal manifestation (MM, i.e. complete remission) | One year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Osserman clinical classification | One year after treatment | |
| Myasthenia gravis (MG) score | One year after treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jiann-Horng Yeh, M.D. | Shin Kong Wu Ho-Su Memorial Hospital | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
1 tablet AZA (50 mg/tab) and 4 tablets MA placebo twice daily |
|
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |