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

PHASE3CompletedINTERVENTIONAL
Enrollment

518

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Ulcerative Colitis
Interventions
BIOLOGICAL

adalimumab

Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 50.

BIOLOGICAL

placebo

Matching Placebo for prefilled syringe, 40 mg,

Trial Locations (108)

1070

Site Ref # / Investigator 5253, Brussels

1090

Site Ref # / Investigator 9802, Vienna

1148

Site Ref # / Investigator 13181, Auckland

1200

Site Ref # / Investigator 6225, Brussels

2605

Site Ref # / Investigator 13722, Garran

2819

Site Ref # / Investigator 9561, Gjøvik

2820

Site Ref # / Investigator 5256, Bonheiden

3000

Site Ref # / Investigator 6078, Leuven

3010

Site Ref # / Investigator 10222, Bern

3128

Site Ref # / Investigator 14882, Box Hill

3144

Site Ref # / Investigator 9002, Malvern

4029

Site Ref # / Investigator 13723, Herston

4031

Site Ref # / Investigator 10221, Basel

4032

Site Ref # / Investigator 10625, Debrecen

5000

Site Ref # / Investigator 7477, Odense C

5700

Site Ref # / Investigator 14104, Gyula

6160

Site Ref # / Investigator 10704, Fremantle

7006

Site Ref # / Investigator 5193, Trondheim

8011

Site Ref # / Investigator 13148, Christchurch

8091

Site Ref # / Investigator 9162, Zurich

9000

Site Ref # / Investigator 6079, Ghent

9038

Site Ref # / Investigator 5194, Tromsø

11021

Site Ref # / Investigator 3756, Great Neck

15006

Site Ref # / Investigator 7479, Prague

18840

Site Ref # / Investigator 3765, Sayre

20148

Site Ref # / Investigator 15321, Hamburg

21093

Site Ref # / Investigator 3738, Lutherville

21401

Site Ref # / Investigator 3759, Annapolis

Site Ref # / Investigator 3762, Annapolis

22559

Site Ref # / Investigator 9069, Hamburg

28040

Site Ref # / Investigator 5212, Madrid

28207

Site Ref # / Investigator 3752, Charlotte

28546

Site Ref # / Investigator 3758, Jacksonville

29204

Site Ref # / Investigator 3741, Columbia

30342

Site Ref # / Investigator 3739, Atlanta

31059

Site Ref # / Investigator 7474, Toulouse

31201

Site Ref # / Investigator 7658, Macon

32256

Site Ref # / Investigator 5106, Jacksonville

32423

Site Ref # / Investigator 9067, Minden

32607

Site Ref # / Investigator 12903, Gainesville

32789

Site Ref # / Investigator 3742, Winter Park

33021

Site Ref # / Investigator 3747, Hollywood

33542

Site Ref # / Investigator 3760, Zephyrhills

33600

Site Ref # / Investigator 7475, Pessac

34102

Site Ref # / Investigator 11601, Naples

34239

Site Ref # / Investigator 6846, Sarasota

37203

Site Ref # / Investigator 6077, Nashville

37205

Site Ref # / Investigator 5107, Nashville

38138

Site Ref # / Investigator 3737, Germantown

39120

Site Ref # / Investigator 14642, Magdeburg

44281

Site Ref # / Investigator 12744, Kfar Saba

45219

Site Ref # / Investigator 3745, Cincinnati

48098

Site Ref # / Investigator 7472, Troy

48159

Site Ref # / Investigator 14761, Münster

49100

Site Ref # / Investigator 10623, Petah Tikva

53095

Site Ref # / Investigator 3761, West Bend

55905

Site Ref # / Investigator 3744, Rochester

59037

Site Ref # / Investigator 7476, Lille

61265

Site Ref # / Investigator 5397, Moline

63128

Site Ref # / Investigator 6088, St Louis

64239

Site Ref # / Investigator 15361, Tel Aviv

66606

Site Ref # / Investigator 7453, Topeka

73104

Site Ref # / Investigator 7709, Oklahoma City

74104

Site Ref # / Investigator 3740, Tulsa

80033

Site Ref # / Investigator 3753, Wheat Ridge

80639

Site Ref # / Investigator 14661, Munich

81377

Site Ref # / Investigator 9801, Munich

84405

Site Ref # / Investigator 5398, Ogden

92110

Site Ref # / Investigator 6231, Clichy

92801

Site Ref # / Investigator 5394, Anaheim

93053

Site Ref # / Investigator 5247, Regensburg

99202

Site Ref # / Investigator 8064, Spokane

99204

Site Ref # / Investigator 3750, Spokane

06518

Site Ref # / Investigator 3754, Hamden

37212-1610

Site Ref # / Investigator 3743, Nashville

C1181ACH

Site Ref # / Investigator 6853, Buenos Aires

NSW 2200

Site Ref # / Investigator 16141, Bankstown

SA 5042

Site Ref # / Investigator 10706, Bedford Park

B1Y 1Z9

Site Ref # / Investigator 10423, Kelowna

V8T 5G4

Site Ref # / Investigator 3766, Victoria

P3E 2N8

Site Ref # / Investigator 13556, Greater Sudbury

L8N 3Z5

Site Ref # / Investigator 3769, Hamilton

M5G 1X5

Site Ref # / Investigator 3736, Toronto

H3A 1A1

Site Ref # / Investigator 3771, Montreal

H3G 1A4

Site Ref # / Investigator 3764, Montreal

H3T 1E2

Site Ref # / Investigator 3768, Montreal

G1S 4L8

Site Ref # / Investigator 3770, Québec

370 87

Site Ref # / Investigator 7021, České Budějovice

500 12

Site Ref # / Investigator 6307, Hradec Kravlove 12

775 20

Site Ref # / Investigator 6606, Olomouc

140 21

Site Ref # / Investigator 7481, Prague

DK-2650

Site Ref # / Investigator 6483, Hvidovre

H-1076

Site Ref # / Investigator 7485, Budapest

H-1135

Site Ref # / Investigator 5025, Budapest

H-3051

Site Ref # / Investigator 4987, Miskoic

H-3526

Site Ref # / Investigator 5036, Miskolc

0620

Site Ref # / Investigator 13301, Auckland

Unknown

Site Ref # / Investigator 13482, Hamilton

0027

Site Ref # / Investigator 5197, Oslo

0514

Site Ref # / Investigator 6297, Oslo

90-153

Site Ref # / Investigator 5242, Lodz

02 781

Site Ref # / Investigator 5266, Warsaw

02-507

Site Ref # / Investigator 5265, Warsaw

54-144

Site Ref # / Investigator 15263, Wroclaw

8000-386

Site Ref # / Investigator 5264, Faro

1150-314

Site Ref # / Investigator 7473, Lisbon

1769-001

Site Ref # / Investigator 5263, Lisbon

08036

Site Ref # / Investigator 5211, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY

NCT00408629 - Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis | Biotech Hunter | Biotech Hunter