A Study of Abatacept in Patients With Active Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

591

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

June 30, 2009

Study Completion Date

November 30, 2009

Conditions
Ulcerative Colitis
Interventions
DRUG

abatacept (ABA)

"Dextrose 5% in water, IV. Placebo on days IP-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; 10 mg/kg on days IP-1, IP-15,IP-29, IP-57; or 30 mg/kg on days IP-1,IP-15 and \~10 mg/kg on days IP-29, IP-57 (ABA 30/\~10 mg/kg Group).~Induction Period 3 months~Maintenance Period 12 months"

DRUG

placebo

"Normal saline, IV, 0 mg/kg, every 28 days.~Induction Period 3 months~Maintenance Period 12 months"

DRUG

abatacept

"\~10 mg/kg, once monthly~Open- Label Extension Period until the drug is marketed for UC or the UC development program for abatacept is discontinued"

Trial Locations (143)

1200

Local Institution, Brussels

2050

Local Institution, Camperdown

2193

Local Institution, Parktown West

2605

Local Institution, Garran

3000

Local Institution, Leuven

3010

Local Institution, Bern

3128

Local Institution, Box Hill

3350

Local Institution, South Ballarat

4029

Local Institution, Herston

4091

Local Institution, Overport

4101

Local Institution, South Brisbane

5042

Local Institution, Bedford Park

6160

Local Institution, Fremantle

7250

Local Institution, Launceston

7350

Local Institution, Belville

7506

Local Institution, Panorama

8091

Local Institution, Zurich

10029

Mount Sinai School Of Medicine, New York

11021

Long Island Clinical Research, Great Neck

11075

Local Institution, Santos

11560

Local Institution, Df

11570

Good, Larry I., Rockville Centre

11733

Gastrointestinal Resrch Assoc., Setauket

12524

Hudson Valley Medical Research Llc, Fishkill

13070

Local Institution, Campinas

14080

Local Institution, Mexico City

14642

University Of Rochester Medical Center, Rochester

15212

Allegheny Center For Digestive Health, Pittsburgh

19104

Hospital Of The University Of Pennsylvania, Philadelphia

21941

Local Institution, Rio de Janeiro

24105

Local Institution, Kiel

27103

Piedmont Medical Research Associates, Winston-Salem

27250

Local Institution, Torreón

27599

University Of North Carolina, Chapel Hill

28207

Charlotte Gastroenterology & Hepatology, Pllc, Charlotte

28401

Hanover Medical Specialists, P.A., Wilmington

29425

Medical University Of South Carolina, Charleston

30342

Atlanta Gastroenterology Associates, Atlanta

31059

Local Institution, Toulouse

31238

Local Institution, Chihuahua City

32256

Borland-Groover Clinic, Jacksonville

32610

University Of Florida, Gainesville

32789

Shafran Gasteroenterology Center, Winter Park

33143

Miami Research Associates, Miami

33604

Local Institution, Pessac

35128

Local Institution, Padua

35294

University Of Alabama At Birmingham, Birmingham

37205

Nashville Medical Research, Nashville

38138

Gastroenterology Center Of The Midsouth, P.C., Germantown

Memphis Gastroenterology Group, Germantown

40202

University Of Louisville, Louisville

40536

University Of Kentucky Chandler Medical Center, Lexington

42700

Local Institution, Salvador

44160

Local Institution, Guadalajara

44200

Local Institution, Guadalajara

44340

Local Institution, Guadalajara

44718

Gastroenterology Specialists, Inc., Canton

45050

Local Institution, Guadalajara

45200

Local Institution, Guadalajara

45219

Consultants For Clinical Research, Inc., Cincinnati

45415

Gastrointestinal & Liver Diseases Consultants, Dayton

48129

Local Institution, Münster

48159

Local Institution, Münster

55446

Minnesota Gastroenterology, P.A., Plymouth

55905

Mayo Clinic Rochester, Rochester

59037

Local Institution, Lille

60612

Rush University Medical Center, Chicago

60637

University Of Chicago Hospitals, Chicago

64131

Kansas City Gastroenterology And Hepatology, Kansas City

64460

Local Institution, Monterrey

65265

Center For Digestive & Liver Diseases, Inc., Mexico

67124

Health Science Center, Pratt

70503

Gulf Coast Research, Lafayette

71013

Local Institution, San Giovanni Rotondo

73104

Oklahoma Foundation For Digestive Research, Oklahoma City

74104

Options Health Research, Llc, Tulsa

74135

Healthcare Research Consultants, Tulsa

74535

Local Institution, Goiânia

75475

Local Institution, Paris

78215

Alamo Medical Research, San Antonio

78229

Gastroenterology Clinic Of San Antonio, San Antonio

78705

Austin Gastroenterology, Pa, Austin

80033

Western States Clinical Research Inc., Wheat Ridge

80054

Local Institution, Amiens

80060

Local Institution, Curitiba

80138

Local Institution, Napoli

80230

Local Institution, Culiacán

83280

Local Institution, Hermosillo

85259

Mayo Clinic Arizona, Scottsdale

90035

Local Institution, Porto Alegre

90048

Cedars-Sinai Medical Center, Los Angeles

90610

Local Institution, Porto Alegre

92110

Local Institution, Clichy

95825

The Permanente Medical Group, Inc, Sacramento

98101

Virginia Mason Medical Center, Seattle

98405

Tacoma Digestive Disease Research Ctr., Tacoma

110076

Local Institution, Delhi

400020

Local Institution, Mumbai

500058

Local Institution, Hyderabad

500082

Local Institution, Hyderabad

560017

Local Institution, Bangalore

560034

Local Institution, Bangalore

570004

Local Institution, Mysore

575001

Local Institution, Mangalore

576104

Local Institution, Manipal

682304

Local Institution, Kochi

06790

Litchfield County Gastroenterology Assoc., Torrington

01610

Clinical Pharmacology Study Group, Worcester

08234

Aga Clinical Research Associates, Llc, Egg Harbor Twp

3065 VIC

Local Institution, Fitzroy

09060

Local Institution, Santo Andre - Sp

01246

Local Institution, São Paulo

V5Z 1H2

Local Institution, Vancouver

V6Z 2K5

Local Institution, Vancouver

K7L 5G2

Local Institution, Kingston

N6A 5A5

Local Institution, London

K1H 8L6

Local Institution, Ottawa

M3N 2V7

Local Institution, Toronto

M5G 1X5

Local Institution, Toronto

G6V 3Z1

Local Institution, Lévis

H1T 2M4

Local Institution, Montreal

G1L 3L5

Local Institution, Québec

625 00

Local Institution, Brno - Bohunice

370 87

Local Institution, České Budějovice

06200

Local Institution, Nice

400 022

Local Institution, Mumbai

400 029

Local Institution, Mumbai

Unknown

Local Institution, Dublin

00133

Local Institution, Roma

00152

Local Institution, Roma

06726

Local Institution, Mexico, D. F.

3816 CP

Local Institution, Amersfoort

1105 AZ

Local Institution, Amsterdam

9700 RB

Local Institution, Groningen

40-752

Local Institution, Katowice

02-781

Local Institution, Warsaw

50-326

Local Institution, Wroclaw

00716

Local Institution, Ponce

0048

Local Institution, Pretoria

120-752

Local Institution, Seoul

E1 1BB

Local Institution, London

WC1E 6DB

Local Institution, London

OX 39DU

Local Institution, Oxford

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY