A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease(SSc-ILD)
Sponsor: |
Boehringer Ingelheim |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ1310 |
Contact: |
Nina Patel: 212-342-6924 / np2199@cumc.columbia.edu |
This study is for patients with systemic sclerosis (SSc) and associated Interstitial Lung Disease. Systemic sclerosis or systemic scleroderma is a disease that causes thickening of the skin and the internal organs which often includes the kidneys, heart, lungs and gastrointestinal tract. Your disease affects the skin but also it affects the lungs. As the lung tissue becomes more thick and scarred, your lungs lose their ability to move oxygen into your bloodstream. The purpose of this study is to investigate how well the treatment with the study drug called nintedanib can demonstrate a slowing of the rate of lung scarring (or fibrosis) and how well the study treatment has an effect on the skin thickening as well as investigate the safety of nintedanib and how well the body tolerates the drug. Patients will either be assigned the study drug or given a placebo. A placebo is a substance that looks like the study drug but contains no active drug.
This study is closed
Investigator
Nina Patel, MD
Do you have systemic sclerosis (SSc) and associated Interstitial Lung Disease? |
Yes |
No |