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

Completed

• Conditions: Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
• Interventions: Drug: tacrolimus

• Registration Number: NCT02159651
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-01
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-10
• Primary Completion: 2019-12-23
• Study Completion: 2019-12-23
• Status Verified: 2020-04
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Hospitalized patient
• Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2: Polymyositis group	tacrolimus	patients with interstitial pneumonia associated with polymyositis
1: Dermatomyositis group	tacrolimus	patients with interstitial pneumonia associated with dermatomyositis

Primary Outcome Measures

Name	Time	Method
Overall survival	Up to three years

Secondary Outcome Measures

Name	Time	Method
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
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)
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
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).
Chest CT findings	Up to three years	CT: computed tomography
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