A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia

Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis Clinical Trial

Official title:

Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159651
• Other study ID #: PRGI01
• Secondary ID: 506-MA-PRGI-01
• Status: Completed
• Start date: April 1, 2014
• Est. completion date: December 23, 2019

Study information

• Verified date: April 2020
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hospitalized patient

• Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis

Related Conditions & MeSH terms

• Dermatomyositis
• Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
• Lung Diseases, Interstitial
• Pneumonia
• Polymyositis

Intervention

Drug:
• tacrolimus
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Up to three years
Secondary	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
Secondary	Arterial blood gas analysis value (PaO2, AaDO2)	Arterial blood gas analysis by PaO2 (arterial O2 pressure) and AaDO2 (alveolar-arterial oxygen difference)	Up to three years
Secondary	Chest CT findings	CT: computed tomography	Up to three years
Secondary	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
Secondary	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
Secondary	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