Studies Evaluating Filgotinib in Subjects with Moderately to Severely Active Crohn’s Disease (Gilead 95) (H-41352)
Description
Content
What is the purpose of this study?
The purpose of this study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of clinical remission, as well as, endoscopic response (3 treatment groups)
Who is eligible to participate?
Moderately to severely active Crohn's Disease (of at least 3 months)
No current strictures or stenoses, short gut syndrome, Fistulae (excluding perianal) or manifestations that may require surgery
Must have previously failed or been intolerant to 1 or more approved biologic agents (Humira, Cimzia, Remicade, Entyvio, Stelara.) OR Never have had Biologic treatment, but failed immunomodulators (Azathioprine, 6-MP, Methotrexate) or corticosteroids.
Willing to return every month for study visits for duration of the study
The study coordinator will review medical and eligibility requirements by phone while setting up the first appointment. A consent form will be provided at the initial visit.
What is involved?
Subjects participating in the control project will be asked to make annual clinic visits at Baylor College of Medicine, located on the 8th floor of the McNair Building, 7200 Cambridge St, Houston, TX 77030. At the initial visit, a consent form explaining the study will be presented. Eligible subjects will be asked questions about their medical history and current medications. Subjects will also be given a brief physical exam (including vital signs) and routine blood work. The clinic visits will take about three and half hours. Once enrolled in the study, each subject will be asked to return monthly. Visits could include, vital signs, exams, brief questionnaires, blood work, stool samples, ECG, Colonoscopy (twice throughout the study), infusion and subcutaneous injections.
How much will this cost?
All research related procedures are FREE to you. Stipend for travel and time will also be included.
Who can I contact?
Alexys Nunn, Research Coordinator 713-798-3099
Joanna Cyrus David, Research Coordinator 713-798-1468
Contact
Alexys Nunn, Research Coordinator
Phone 1: 713–798–3099
IRB: H-41352
Status:
Active
Created:
