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| ID | Type | Description | Link |
|---|---|---|---|
| 506-MA-PRGI-01 | Other Identifier | Japan Medical Affairs |
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This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Dermatomyositis group | patients with interstitial pneumonia associated with dermatomyositis |
| |
| 2: Polymyositis group | patients with interstitial pneumonia associated with polymyositis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Up to three years |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory function test value (%FVC, %DLco) | Respiratory function is evaluated by % FVC ( percent-predicted forced vital capacity) amd %DLco (diffusion capacity of CO). | Up to three years |
| Arterial blood gas analysis value (PaO2, AaDO2) |
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Inclusion Criteria:
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Patients with interstitial pneumonia associated with polymyositis/dermatomyositis who treated with Prograf
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35428708 | Derived | Kuwana M, Wakasugi N, Furuya T, Uno S, Suda T. Tacrolimus in Patients With Interstitial Pneumonia Associated With Polymyositis or Dermatomyositis: Interim Report of Postmarketing Surveillance in Japan. J Rheumatol. 2022 Jul;49(7):707-718. doi: 10.3899/jrheum.210322. Epub 2022 Apr 15. |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D003882 | Dermatomyositis |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D017285 | Polymyositis |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Arterial blood gas analysis by PaO2 (arterial O2 pressure) and AaDO2 (alveolar-arterial oxygen difference)
| Up to three years |
| Chest CT findings | CT: computed tomography | Up to three years |
| Serum KL-6 value (serum SP-D value) | KL-6 (sialylated carbohydrate antigen KL-6) and SP-D (surfactant protein D) are used as marker of interstitial pneumonia | Up to three years |
| Patient disposition | patient disposition includes 1)number of case report forms collected, 2)number of patients analyzed for safety, 3)number of patients analysed for efficacy | Up to three years |
| Safety assessed by the incidence of adverse events | Any adverse events which include adverse events leading to death, white blood cell count, erythrocyte sedimentation rate and other abnormal findings from laboratory tests | Up to three years |
| Chūbu |
| Japan |
| Hokkaido | Japan |
| Kansai | Japan |
| Kanto | Japan |
| Kyushu | Japan |
| Shikoku | Japan |
| Tōhoku | Japan |
| D009468 |
| Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |