The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,173
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests
Time frame: Up to 336 weeks plus 30 days
Change From Baseline in Components of Mayo Clinic Score (MCS)
Time frame: Baseline and up to 336 weeks
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Digestive Health Specialists Of The Southeast
Dothan, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
South Denver Gastroenterology, PC
Lone Tree, Colorado, United States
Connecticut GI PC-Research Division
Farmington, Connecticut, United States
UF Clinical Research Center
Gainesville, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
University of Miami Crohn's and Colitis Center
Miami, Florida, United States
Cordova Research Institute
Miami, Florida, United States
...and 313 more locations