General Study Questions
Are there any possible benefits of being in the study?
Taking part in this study may or may not help your lung disease. Your health could improve, stay the same, or get worse. However, the data we get from your participation may help us learn more about the study drug and whether or not it benefits people who have interstitial lung disease (ILD) associated with connective tissue disease. This information may help patients in the future.
Are there any possible risks from the study treatment?
Like all medicines and vaccines, the study drug may cause side effects, although not everyone gets them. Your health will be closely monitored during the entire study. It is very important to tell the study doctor if you notice any changes in your health or if anything is bothering you.
While the study drug is approved to treat another disease and is well tolerated, it is not approved for patients with ILD.
How long will I be in the study?
The BEconneCTD-ILD Study lasts 66 weeks, including 52 weeks (1 year) of study treatment. If you complete the 52-week Study Treatment Period, you may be eligible to join the Long-Term Extension Study, where you would receive the active study drug (no placebo) for at least 52 weeks.
Will it cost me anything to be in the study?
Taking part in the study will not cost you anything. You will not be charged for the study drug or any of the tests that are part of this study. The sponsor will not pay for doctor visits or other treatments or tests that are not part of this study.
Who is sponsoring the study?
GSK, a global pharmaceutical company, is sponsoring the study. They provide the funding for doctors and study sites to conduct this study.
What if I decide to join the study and then change my mind?
Being in the study is completely voluntary. If you decide to join and then change your mind, you can leave the study at any time.
If you leave the study early or if you stop taking the study drug early, the study doctor will ask you to complete one more visit, which may include a final health exam and lab tests, for your own safety.
What’s the first step I should take?
If you are interested in learning more, ask the doctor who treats your connective tissue disease about the BEconneCTD-ILD Study.