Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

576

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

April 30, 2009

Study Completion Date

March 31, 2010

Conditions
Ulcerative Colitis
Interventions
BIOLOGICAL

adalimumab

Prefilled syringe, 40 mg (loading dose then every other week dosing). 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.

BIOLOGICAL

adalimumab

Prefilled syringe, 40 mg (loading dose then every other week dosing). 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.

BIOLOGICAL

placebo

Placebo for 40 mg syringe. Matching placebo for loading dose and every other week dosing. Subjects received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab eow thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).

Trial Locations (80)

1030

Site Ref # / Investigator 4937, Vienna

1090

Site Ref # / Investigator 3831, Vienna

2820

Site Ref # / Investigator 3861, Bonheiden

4000

Site Ref # / Investigator 3859, Liège

6060

Site Ref # / Investigator 6224, Hall in Tirol

8036

Site Ref # / Investigator 4936, Graz

8800

Site Ref # / Investigator 3862, Roeselare

10028

Site Ref # / Investigator 2072, New York

13353

Site Ref # / Investigator 3832, Berlin

17000

Site Ref # / Investigator 3855, Prague

20157

Site Ref # / Investigator 3848, Milan

20815

Site Ref # / Investigator 2078, Chevy Chase

20901

Site Ref # / Investigator 2238, Silver Springs

22185

Site Ref # / Investigator 8502, Lund

24105

Site Ref # / Investigator 3833, Kiel

27612

Site Ref # / Investigator 2232, Raleigh

28211

Site Ref # / Investigator 2241, Charlotte

28403

Site Ref # / Investigator 11801, Wilmington

30308

Site Ref # / Investigator 5393, Atlanta

30342

Site Ref # / Investigator 2231, Atlanta

32610

Site Ref # / Investigator 2240, Gainesville

33143

Site Ref # / Investigator 2230, South Miami

35209

Site Ref # / Investigator 2080, Birmingham

36617

Site Ref # / Investigator 6034, Mobile

37203

Site Ref # / Investigator 2076, Nashville

38138

Site Ref # / Investigator 6090, Germantown

40138

Site Ref # / Investigator 3876, Bologna

41345

Site Ref # / Investigator 8503, Gothenburg

45219

Site Ref # / Investigator 2074, Cincinnati

53215

Site Ref # / Investigator 2077, Milwaukee

55131

Site Ref # / Investigator 3878, Mainz

55905

Site Ref # / Investigator 2246, Rochester

60637

Site Ref # / Investigator 2498, Chicago

62500

Site Ref # / Investigator 3858, Brno

64131

Site Ref # / Investigator 2243, Kansas City

65265

Site Ref # / Investigator 2247, Mexico

68503

Site Ref # / Investigator 2233, Lincoln

72703

Site Ref # / Investigator 5100, Fayetteville

77520

Site Ref # / Investigator 3856, Olomouc

81377

Site Ref # / Investigator 3897, Munich

90146

Site Ref # / Investigator 3845, Palermo

91101

Site Ref # / Investigator 14521, Trenčín

92123

Site Ref # / Investigator 5392, San Diego

92868

Site Ref # / Investigator 5390, Orange

98004

Site Ref # / Investigator 2229, Bellevue

06606

Site Ref # / Investigator 2245, Bridgeport

02114

Site Ref # / Investigator 1971, Boston

07927

Site Ref # / Investigator 2236, Cedar Knolls

44106-5066

Site Ref # / Investigator 2126, Cleveland

A-6020

Site Ref # / Investigator 3830, Innsbruck

A-4010

Site Ref # / Investigator 7508, Linz

A-5020

Site Ref # / Investigator 3829, Salzburg

T2N 4Z6

Site Ref # / Investigator 2224, Calgary

T6G 2X8

Site Ref # / Investigator 2227, Edmonton

V6Z-2K5

Site Ref # / Investigator 2226, Vancouver

R3A 1R9

Site Ref # / Investigator 2223, Winnipeg

M3N 2V7

Site Ref # / Investigator 2138, Toronto

708 52

Site Ref # / Investigator 3857, Ostrava

118 83

Site Ref # / Investigator 3854, Prague

D-45239

Site Ref # / Investigator 13983, Essen

07747

Site Ref # / Investigator 3834, Jena

H-1076

Site Ref # / Investigator 3852, Budapest

H-1125

Site Ref # / Investigator 3850, Budapest

H-9024

Site Ref # / Investigator 3849, Győr

00133

Site Ref # / Investigator 6232, Rome

00152

Site Ref # / Investigator 3846, Rome

5623 EJ

Site Ref # / Investigator 3873, Eindhoven

2333 ZA

Site Ref # / Investigator 3875, Leiden

90-153

Site Ref # / Investigator 8061, Lodz

81-756

Site Ref # / Investigator 13804, Sopot

02-507

Site Ref # / Investigator 8055, Warsaw

00717

Site Ref # / Investigator 2392, Ponce

00936-5067

Site Ref # / Investigator 2393, San Juan

97 401

Site Ref # / Investigator 3839, Banská Bystrica

811 07

Site Ref # / Investigator 3838, Bratislava

833 05

Site Ref # / Investigator 3841, Bratislava

94 901

Site Ref # / Investigator 3842, Nitra

08001

Site Ref # / Investigator 14721, Prešov

917 01

Site Ref # / Investigator 3840, Trnava

581 85

Site Ref # / Investigator 8504, Linköping

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY