ornito schreef op 6 februari 2019 08:09:
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www.myibdstudy.com/Public/Home/Divers...What does the study involve? The study will consist of 14-21 visits. The visits are 1-8 weeks apart, over a period of approximately 58 weeks (about one year).
During the study, you may be able to continue some of your current drugs in addition to the study drugs.
In addition to your current drugs, people in this study may receive filgotinib or placebo (an inactive substance that looks like the study drug).
Everyone who enrolls will be randomly assigned to receive one of two doses of the investigational drug or placebo (an inactive substance).
Neither you nor the study doctor will know whether you are taking active filgotinib or placebo.
Two out of three participants will receive active filgotinib during the initial 10 weeks of the study. If you respond favorably to the study drug during this period, you will move on to the next stage at week 11.
At week 11, two out of three participants assigned to receive active filgotinib will continue to receive it for the remainder of the study. One in three will move to placebo, and participants already on placebo who are responding favorably will remain on it.
People whose symptoms get worse after 10 weeks in the study may be eligible to receive active filgotinib in a separate long-term extension study.