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Clinical Trial Details

Title
An open-label extension trial to assess the long term safety of nintedanib in patients with "Systemic Sclerosis associated Interstitial Lung Disease" (SSC-ILD)
Study Description

This study is being done to evaluate the long-term safety and tolerability of the study drug called nintedanib in subjects with Systemic Sclerosis and associated Interstitial Lung Disease.

In the parent study you were treated with either 150 mg or 100 mg of study drug taken twice daily (either nintedanib or placebo to nintedanib). In the parent study, no one (including you and the study team) knew what study drug you received. In this extension study, you will receive the study drug as follows: • If you completed the parent study on 150 mg of study drug treatment twice daily, your initial study drug treatment in this extension study will be nintedanib 150 mg capsules taken twice daily. • If you completed the parent study on 100 mg of study drug treatment twice daily, you may either start with nintedanib 100 mg capsules taken twice daily or with nintedanib 150 mg capsules taken twice daily. Your study doctor will discuss the best option with you. Both you and the study doctor will know what dose of the study drug you get. You will take one capsule of the study drug two times a day about twelve hours apart. You will take the study drug about the same time every morning between 06:00 AM and 11:00 AM and between 6:00 PM and 11:00 PM in the evening. You will take the study drug with about a glass of water. Because the study drug may cause stomach discomfort it is recommended that you take the study drug with food. If a dose is missed, the dose should be skipped if the time remaining to the next dose is less than eight hours, and the next dose should be taken as scheduled.

Open Enrollment
Contact Name: Lisa Jones
Contact Phone: (904) 244-4075
Contact Email: lisa.jones@jax.ufl.edu
Investigators

Principal Investigator
Lisa M. Jones, M.D.
Medicine