This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
950
Upadacitinib (ABT-494) will be administered orally.
Placebo will be administered orally.
Assessing Treatment-Emergent Adverse Events
Treatment-emergent adverse events are defined as events that begin or worsen either on or after the first dose of the study drug and within 30 days after the last dose of the study drug in the analysis period.
Time frame: Up to 288 Weeks
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East View Medical Research, LLC /ID# 171184
Mobile, Alabama, United States
CB Flock Research Corporation /ID# 165986
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Delsol Research Management, Ll /Id# 170130
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Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211886
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Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 169823
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Adobe Clinical Research LLC /ID# 155249
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Duplicate_University of Arizona /ID# 150568
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Citrus Valley Gastroenterology /ID# 151915
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