A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

November 30, 2005

Study Completion Date

October 31, 2006

Conditions
Crohn Disease
Interventions
DRUG

Ustekinumab 90 mg

one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)

DRUG

Ustekinumab 4.5 mg/kg

one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2

DRUG

Placebo SC

one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2)

DRUG

Placebo IV

one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1

Trial Locations (57)

Unknown

Scottsdale

Anaheim

Sacramento

San Francisco

Bristol

New Haven

Jacksonville

Miami

Indianapolis

Topeka

Lexington

Louisville

Baton Rouge

Metairie

New Orleans

Laurel

Chesterfield

Troy

Rochester

Omaha

Great Neck

New York

Chapel Hill

Charlotte

Cincinnati

Cleveland

Columbus

Oklahoma City

Portland

Beaver Falls

Pittsburgh

Providence

Columbia

Germantown

Knoxville

Memphis

Nashville

Austin

Dallas

Houston

Ogden

Salt Lake City

Charlottesville

Christiansburg

Richmond

Everett

Seattle

Tacoma

Madison

Milwaukee

Leuven

Edmonton

Vancouver

Winnipeg

Toronto

Hamilton

London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Centocor, Inc.

INDUSTRY