The objective of this study is to assess the efficacy and safety of adalimumab for the
induction of clinical remission in subjects with moderately to severely active ulcerative
colitis.
Analysis Set - Induction" in the participant flow). For the analysis of efficacy parameters
during the OL Period through Week 52, all randomized participants (under any version of the
protocol) who received at least 1 dose of study drug were considered ("Efficacy Analysis Set
- Maintenance" in the participant flow). For the analysis of safety parameters, all
participants who received at least 1 dose of study drug were considered ("Safety Analysis
Set" in the participant flow).
Twelve ranked secondary variables during the DB Period through Week 8 were to be tested in a
hierarchical order to account for multiple testing. These variables are identified as
"Ranked Secondary Endpoints" in the results section below. Additionally, non-ranked
secondary variables during the OL Period through Week 52 were tested and are presented after
the ranked secondary endpoints in the results section below.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Site Ref # / Investigator 4936, Graz 8036, Austria
Site Ref # / Investigator 6224, Hall 6060, Austria
Site Ref # / Investigator 3830, Innsbruck A-6020, Austria
Site Ref # / Investigator 7508, Linz A-4010, Austria
Site Ref # / Investigator 3829, Salzburg A-5020, Austria
Site Ref # / Investigator 3831, Vienna 1090, Austria
Site Ref # / Investigator 4937, Vienna 1030, Austria
Site Ref # / Investigator 3861, Bonheiden 2820, Belgium
Site Ref # / Investigator 3859, Liege 4000, Belgium
Site Ref # / Investigator 3862, Roeselare 8800, Belgium
Site Ref # / Investigator 3858, Brno 62500, Czech Republic
Site Ref # / Investigator 3856, Olomouc 77520, Czech Republic
Site Ref # / Investigator 3857, Ostrava 708 52, Czech Republic
Site Ref # / Investigator 3854, Prague 1 118 83, Czech Republic
Site Ref # / Investigator 3855, Prague 7 17000, Czech Republic
Site Ref # / Investigator 3832, Berlin 13353, Germany
Site Ref # / Investigator 13983, Essen D-45239, Germany
Site Ref # / Investigator 3834, Jena 07747, Germany
Site Ref # / Investigator 3833, Kiel 24105, Germany
Site Ref # / Investigator 3878, Mainz 55131, Germany
Site Ref # / Investigator 3897, Munich 81377, Germany
Site Ref # / Investigator 3850, Budapest H-1125, Hungary
Site Ref # / Investigator 3852, Budapest H-1076, Hungary
Site Ref # / Investigator 3849, Gyor H-9024, Hungary
Site Ref # / Investigator 3876, Bologna 40138, Italy
Site Ref # / Investigator 3848, Milan 20157, Italy
Site Ref # / Investigator 3845, Palermo 90146, Italy
Site Ref # / Investigator 3846, Rome 00152, Italy
Site Ref # / Investigator 6232, Rome 00133, Italy
Site Ref # / Investigator 3873, Eindhoven 5623 EJ, Netherlands
Site Ref # / Investigator 3875, Leiden 2333 ZA, Netherlands
Site Ref # / Investigator 8061, Lodz 90-153, Poland
Site Ref # / Investigator 13804, Sopot 81-756, Poland
Site Ref # / Investigator 8055, Warsaw 02-507, Poland
Site Ref # / Investigator 2392, Ponce 00717, Puerto Rico
Site Ref # / Investigator 2393, San Juan 00936-5067, Puerto Rico
Site Ref # / Investigator 3839, Banska Bystrica 97 401, Slovakia
Site Ref # / Investigator 3838, Bratislava 811 07, Slovakia
Site Ref # / Investigator 3841, Bratislava 833 05, Slovakia
Site Ref # / Investigator 3842, Nitra 94 901, Slovakia
Site Ref # / Investigator 14721, Presov 08001, Slovakia
Site Ref # / Investigator 14521, Trencin 91101, Slovakia
Site Ref # / Investigator 3840, Trnava 917 01, Slovakia
Site Ref # / Investigator 8503, Gothenburg 41345, Sweden
Site Ref # / Investigator 8504, Linkoping 581 85, Sweden
Site Ref # / Investigator 8502, Lund 22185, Sweden
Site Ref # / Investigator 2080, Birmingham, Alabama 35209, United States
Site Ref # / Investigator 6034, Mobile, Alabama 36617, United States
Site Ref # / Investigator 2224, Calgary, Alberta T2N 4Z6, Canada
Site Ref # / Investigator 2227, Edmonton, Alberta T6G 2X8, Canada
Site Ref # / Investigator 5100, Fayetteville, Arkansas 72703, United States
Site Ref # / Investigator 2226, Vancouver, British Columbia V6Z-2K5, Canada
Site Ref # / Investigator 5390, Orange, California 92868, United States
Site Ref # / Investigator 5392, San Diego, California 92123, United States
Site Ref # / Investigator 2245, Bridgeport, Connecticut 06606, United States
Site Ref # / Investigator 2240, Gainesville, Florida 32610, United States
Site Ref # / Investigator 2230, South Miami, Florida 33143, United States
Site Ref # / Investigator 2231, Atlanta, Georgia 30342, United States
Site Ref # / Investigator 5393, Atlanta, Georgia 30308, United States
Site Ref # / Investigator 2498, Chicago, Illinois 60637, United States
Site Ref # / Investigator 2223, Winnipeg, Manitoba R3A 1R9, Canada
Site Ref # / Investigator 2078, Chevy Chase, Maryland 20815, United States
Site Ref # / Investigator 2238, Silver Springs, Maryland 20901, United States
Site Ref # / Investigator 1971, Boston, Massachusetts 02114, United States
Site Ref # / Investigator 2246, Rochester, Minnesota 55905, United States
Site Ref # / Investigator 2243, Kansas City, Missouri 64131, United States
Site Ref # / Investigator 2247, Mexico, Missouri 65265, United States
Site Ref # / Investigator 2233, Lincoln, Nebraska 68503, United States
Site Ref # / Investigator 2236, Cedar Knolls, New Jersey 07927, United States
Site Ref # / Investigator 2072, New York, New York 10028, United States
Site Ref # / Investigator 2241, Charlotte, North Carolina 28211, United States
Site Ref # / Investigator 2232, Raleigh, North Carolina 27612, United States
Site Ref # / Investigator 11801, Wilmington, North Carolina 28403, United States
Site Ref # / Investigator 2074, Cincinnati, Ohio 45219, United States
Site Ref # / Investigator 2126, Cleveland, Ohio 44106-5066, United States
Site Ref # / Investigator 2138, Toronto, Ontario M3N 2V7, Canada
Site Ref # / Investigator 6090, Germantown, Tennessee 38138, United States
Site Ref # / Investigator 2076, Nashville, Tennessee 37203, United States
Site Ref # / Investigator 2229, Bellevue, Washington 98004, United States
Site Ref # / Investigator 2077, Milwaukee, Wisconsin 53215, United States