An observational study to determine biomarkers for prognosis of lung lesions in patients with polymyositis/dermatomyositis complicated by interstitial lung disease
Not Applicable
Recruiting
- Conditions
- Polymyositis/dermatomyositis complicated with interstitial lung disease (PM/DM-ILD)
- Registration Number
- JPRN-UMIN000046198
- Lead Sponsor
- agasaki University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 125
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who have received oral corticosteroids for more than 8 weeks prior to obtaining consent. 2) Patients with malignant tumors. 3) Patients who are using or have used an anti-fibrotic therapy. 4) Patients who have undergone more than lobectomy. 5) Other patients deemed inappropriate by the investigator.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Search for biomarkers associated with change in high-resolution CT fibrosis volume and FVC change at 52 weeks from baseline
- Secondary Outcome Measures
Name Time Method FVC at baseline assessment, 26 weeks, and 52 weeks 5% or more deterioration in relative change in %FVC at 52 weeks 5% or more improvement in relative change in %FVC at 52 weeks 10% or more deterioration in relative change in %FVC at 52 weeks 10% or more improvement in relative change in %FVC at 52 weeks Lung fibrosis score at baseline assessment and at 52 weeks