Study for the Treatment of Crohn's Disease With Adacolumn

PHASE3CompletedINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions
Crohn's Disease
Interventions
DEVICE

Adacolumn

"Ten apheresis sessions:~One hour of Adacolumn Apheresis System procedure per visit. Patient had two procedures per week for the first two weeks followed by one apheresis session per weeks for two weeks (Weeks 1-4). then a week break occurs for rest followed by one apheresis session per week for 4 weeks (weeks 6-9)."

DEVICE

Sham

Sham, ten apheresis sessions within 9 weeks

Trial Locations (37)

11021

Long Island Clinical Research Associates, Great Neck

20815

Metropolitan Gastroenterology Group, Chevy Chase

21287

Johns Hopkins University, Baltimore

27710

University of North Carolina, Division of Digestive Disease & Nutrition, Chapel Hill

Duke University Medical Center, Durham

29203

Columbia Gastroenterology Associates, Columbia

30342

Atlanta Gastroenterology Associates, Atlanta

33162

Venture Research Institute, LLC, North Miami Beach

38138

Memphis Gastroenterology Group, Germantown

40536

University of Kentucky Medical Center, Lexington

44195

Cleveland Clinic Foundation, Cleveland

45219

Consultants for Clinical Research, Cincinnati

48047

Clinical Research Institute of Michigan, Clinton Township

48109

University of Michigan, Ann Arbor

53226

Medical College of Wisconsin, Madison

53792

University of Wisconsin-Madison, Madison

60637

University of Chicago, Chicago

77555

University of Texas Medical Branch, Galveston

80033

Rocky Mountain Gastroenterology Associates, PC, Wheat Ridge

85054

Mayo Clinic Scottsdale, Phoenix

94115

UCSF Mount Zion Medical Center, San Francisco

98195

University of Washington Medical Center, Seattle

95661-3037

Capitol Gastroenterology Consultants Medical Group, Roseville

06518

Medical Research Institute of Connecticut, Hamden

02114

Massachusetts General Hospital, GI Unit, Boston

03756

Dartmouth-Hitchcock Medical Center, Lebanon

37232-2285

Vanderbilt University Medical Center, Nashville

75390-9016

UT Southwestern Medical Center, Dallas

T6G 2X8

Walter Mackenzie Health Sciences Centre, Edmonton

V2S 3N5

Gastroenterology & Hematology Clinic, Abbotsford

V6Z 1Y6

St. Paul's Hospital, Vancouver

K7L 5G2

Hotel-Dieu Hospital, Kingston

N6A 4G5

London Health Sciences Centre, London

N6A 5A5

London Health Sciences Centre, London

M5B 1W8

St. Michael's Hospital, Toronto

M5G 1X5

Mount Sinai Hospital, Toronto

H3T 1E2

Jewish General Hospital, Montreal

Sponsors
All Listed Sponsors
lead

Otsuka America Pharmaceutical

INDUSTRY