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| Name | Class |
|---|---|
| Astellas Pharma China, Inc. | INDUSTRY |
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To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tacrolimus group | Experimental |
| |
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus capsule | Drug | oral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in quantitative myasthenia gravis (QMG) score for disease severity | Baseline and at 24 weeks | |
| Change from baseline in QMG score for disease severity | Baseline and at 4 weeks | |
| Change from baseline in QMG score for disease severity | Baseline and at 8 weeks | |
| Change from baseline in QMG score for disease severity | Baseline and at 12 weeks | |
| Change from baseline in QMG score for disease severity | Baseline and at 16 weeks | |
| Change from baseline in QMG score for disease severity | Baseline and at 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Osserman classification | Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks | |
| Changes in myasthenia gravis activity of daily living scale | Baseline and at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28861121 | Derived | Zhou L, Liu W, Li W, Li H, Zhang X, Shang H, Zhang X, Bu B, Deng H, Fang Q, Li J, Zhang H, Song Z, Ou C, Yan C, Liu T, Zhou H, Bao J, Lu J, Shi H, Zhao C. Tacrolimus in the treatment of myasthenia gravis in patients with an inadequate response to glucocorticoid therapy: randomized, double-blind, placebo-controlled study conducted in China. Ther Adv Neurol Disord. 2017 Sep;10(9):315-325. doi: 10.1177/1756285617721092. Epub 2017 Jul 26. |
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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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 |
|
| Guangdong |
| China |
| Jiangsu | China |
| Jilin City | China |
| Shandong | China |
| Shanghai | China |
| Sichuan | China |
| Wuhan | China |
| Zhejiang | China |
| 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 |