A Study of Abatacept in Patients With Active Crohn's Disease

PHASE3TerminatedINTERVENTIONAL
Enrollment

451

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Crohn's Disease
Interventions
DRUG

abatacept

"Dextrose 5% in water, intravenous (IV).~Placebo on days Induction Period (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.~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, every 28 days.~Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued"

Trial Locations (101)

1011

Local Institution, Lausanne

2050

Local Institution, Camperdown

2605

Local Institution, Garran

2650

Local Institution, Hvidovre

2820

Local Institution, Bonheiden

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

5000

Local Institution, Odense C

5042

Local Institution, Bedford Park

6160

Local Institution, Fremantle

7250

Local Institution, Launceston

7535

Local Institution, Belville

8000

Local Institution, Arhus C

8091

Local Institution, Zurich

8800

Local Institution, Roeselare

9100

Local Institution, Aalborg

10029

Mount Sinai School Of Medicine, New York

11021

Long Island Clinical Research, Great Neck

13210

University Endoscopy Center, Syracuse

14000

Local Institution, Mexico City

14642

U Of Rochester Gastroenterology And Hepatology, Rochester

15212

Allegheny Center For Digestive Health, Pittsburgh

20707

Maryland Digestive Disease Research, Laurel

24105

Local Institution, Kiel

27103

Piedmont Medical Research Associates, Winston-Salem

27250

Local Institution, Torreón

27599

University Of North Carolina At Chapel Hill, Chapel Hill

28207

Charlotte Gastroenterology & Hepatology, Pllc, Charlotte

30342

Atlanta Gastroenterology Associates, Atlanta

31059

Local Institution, Toulouse

32256

Borland-Groover Clinic, Jacksonville

32610

University Of Florida, Gainesville

32789

Shafran Gasteroenterology Center, Winter Park

33064

Local Institution, Pessac

35128

Local Institution, Padua

35294

University Of Alabama Medical Center, Birmingham

37205

Nashville Medical Research, Nashville

37403

Southeastern Clinical Research, Chattanooga

38138

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

Memphis Gastroenterology Group, Germantown

40202

University Of Louisville, Louisville

40536

University Of Kentucky Medical Center, Lexington

42700

Local Institution, Salvador

44718

Gastroenterology Specialists, Inc., Canton

45219

Consultants For Clinical Research, 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

60637

University Of Chicago Hospitals, Chicago

64131

Kansas City Gastroenterology And Hepatology, Kansas City

64460

Local Institution, Monterrey

67124

Health Science Center, Pratt

70506

Vanderlick, Michael, Lafayette

70808

Gulf Coast Research Assoc, Baton Rouge

71013

Local Institution, San Giovanni Rotondo

74104

Options Health Research, Llc, Tulsa

74535

Local Institution, Goiânia

75475

Local Institution, Paris

78229

Gastroenterology Clinic Of San Antonio, San Antonio

78705

Austin Gastroenterology, Pa, Austin

80054

Local Institution, Amiens

80060

Local Institution, Curitiba

80138

Local Institution, Napoli

90035

Local Institution, Porto Alegre

90048

Cedars-Sinai Medical Center, Los Angeles

95825

The Permanente Medical Group, Inc, Sacramento

98101

Virginia Mason Medical Center, Seattle

500058

Local Institution, Hyderabad

500082

Local Institution, Hyderabad

570004

Local Institution, Mysore

575001

Local Institution, Mangalore

576104

Local Institution, Manipal

08234

Aga Clinical Research Associates, Llc, Egg Harbor Twp

3065 VIC

Local Institution, Fitzroy

01246

Local Institution, São Paulo

T2N 4N1

Local Institution, Calgary

T6G 2X8

Local Institution, Edmonton

V6Z 2K5

Local Institution, Vancouver

A1B 3V6

Local Institution, St. John's

B3H 2Y9

Local Institution, Halifax

N6A 5A5

Local Institution, London

K1H 8L6

Local Institution, Ottawa

M3N 2V7

Local Institution, Toronto

H1T 2M4

Local Institution, Montreal

370 87

Local Institution, České Budějovice

06200

Local Institution, Nice

400 029

Local Institution, Mumbai

00152

Local Institution, Roma

1105 AZ

Local Institution, Amsterdam

9713 GZ

Local Institution, Groningen

3015 CE

Local Institution, Rotterdam

40-752

Local Institution, Katowice

00716

Local Institution, Ponce

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY