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The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.] | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of steroid therapy (mg) | 6 Months | |
| QMG score;MG-ADL | 6 Months | |
| Success rate of achievement to the targeted steroid dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21784757 | Derived | Yoshikawa H, Kiuchi T, Saida T, Takamori M. Randomised, double-blind, placebo-controlled study of tacrolimus in myasthenia gravis. J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):970-7. doi: 10.1136/jnnp-2011-300148. Epub 2011 Jul 22. |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| placebo | Drug | oral |
|
| 6 Months |
| Chugoku Region |
| Japan |
| Hokkaido Region | Japan |
| Hokuriku Region | Japan |
| Kansai Region | Japan |
| Kanto Region | Japan |
| Kyushu Region | Japan |
| Shikoku Region | Japan |
| Tohoku Region | Japan |
| 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 |