Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
Conditions
Keywords
tacrolimus, interstitial pneumonia, prograf
Brief summary
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.
Interventions
DRUGtacrolimus
oral
Sponsors
Astellas Pharma Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Hospitalized patient * Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | Up to three years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial blood gas analysis value (PaO2, AaDO2) | Up to three years | Arterial blood gas analysis by PaO2 (arterial O2 pressure) and AaDO2 (alveolar-arterial oxygen difference) |
| Chest CT findings | Up to three years | CT: computed tomography |
| Respiratory function test value (%FVC, %DLco) | Up to three years | Respiratory function is evaluated by % FVC ( percent-predicted forced vital capacity) amd %DLco (diffusion capacity of CO). |
| Patient disposition | Up to three years | patient disposition includes 1)number of case report forms collected, 2)number of patients analyzed for safety, 3)number of patients analysed for efficacy |
| Safety assessed by the incidence of adverse events | Up to three years | Any adverse events which include adverse events leading to death, white blood cell count, erythrocyte sedimentation rate and other abnormal findings from laboratory tests |
| Serum KL-6 value (serum SP-D value) | Up to three years | KL-6 (sialylated carbohydrate antigen KL-6) and SP-D (surfactant protein D) are used as marker of interstitial pneumonia |
Countries
Japan
Outcome results
None listed