Study Details
Testing the Drug Nintedanib for Adults with Myositis Interstitial Lung Disease
(IRB#: IRB_00170784)
Myositis interstitial lung disease is a disorder that results in the thickening, stiffness, and scarring of the tissues of the lung which makes breathing difficult. This study will test Nintedanib on adults with this disease. The study wants to see if the drug will help people with this disease and is safe. People in the study will be randomly chosen to be treated with the study drug Nintedanib or a placebo. A placebo looks like the drug but without the medication. Being in the study requires up to 11 study visits for about 52 weeks. The visits will be in person at a study clinic or lab and at home. Medical tests will be done to track the health of participants.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 years and older
- Participants of childbearing age must use specific birth control methods
- Confirmed diagnosis of myositis
- Able to speak and read English
Exclusion Criteria
- Planned major surgery during 24 weeks of the study
- Pregnant, breastfeeding, or plan to become pregnant during the study
- Increased bleeding risk
- Moderate to severe muscle disease from myositis with specific criteria
- Moderate to severe arthritis (swelling in joints of the body causing pain)
Will I be paid for my time?
Yes
IRB#: IRB_00170784
PI: Mary Beth Scholand
Department: PULMONARY
Approval Date: 2024-05-08 06:00:00
Specialties: Pulmonary