A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

526

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

May 31, 2010

Study Completion Date

December 31, 2010

Conditions
Crohn's Disease
Interventions
DRUG

Placebo (IP)

Induction phase (Week 0-8) (IP) - Placebo IV group

DRUG

Ustekinumab 1mg/kg (IP)

Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group

DRUG

Ustekinumab 3 mg/kg (IP)

Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group

DRUG

Ustekinumab 6 mg/kg (IP)

Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group

DRUG

Placebo IV - Responder - Placebo SC (MP)

Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16

DRUG

Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)

Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16

DRUG

Ustekinumab IV - Responder - Placebo SC (MP)

Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16

DRUG

Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)

Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16

DRUG

Ustekinumab IV - Nonresponder - Placebo SC (MP)

Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Placebo SC at Week 8 and Week 16

DRUG

Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)

Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16

Trial Locations (174)

Unknown

Mobile

Scottsdale

La Jolla

Los Angeles

Roseville

San Carlos

San Francisco

Englewood

Lakewood

Littleton

Hamden

Gainesville

Hollywood

Jacksonville

Miami

Naples

Panama City

Pembroke Pines

Port Charlotte

Port Orange

South Miami

Tampa

Vero Beach

Winter Park

Zephyrhills

Atlanta

Columbus

Decatur

Macon

Newnan

Arlington Heights

Chicago

Evanston

Indianapolis

Clive

Pratt

Lexington

Louisville

Baltimore

Chevy Chase

Towson

Boston

Burlington

Worcester

Ann Arbor

Chesterfield

Detroit

Troy

Rochester

Ocean Springs

Mexico

Lebanon

Egg Harbor

Great Neck

New York

Poughkeepsie

Setauket

Stony Brook

Chapel Hill

Charlotte

Greenville

Kinston

New Bern

Raleigh

Beavercreek

Cincinnati

Cleveland

Dayton

Oklahoma City

Philadelphia

Charleston

Columbia

Chattanooga

Nashville

Austin

Houston

Lewisville

San Antonio

Ogden

Salt Lake City

Burlington

Charlottesville

Norfolk

Bellevue

Lakewood

Seattle

Tacoma

Madison

Adelaide

Bankstown

Bedford Park

Box Hill

Concord

East Melbourne

Fitzroy

Frankston

Fremantle

Garran

Herston

Parkville

Prahran

South Brisbane

Innsbruck

Linz

Salzburg

Vienna

Bonheiden

Brussels

Edegem

Kortrijk

Leuven

Liège

Roeselare

Calgary

Edmonton

Vancouver

Victoria

Hamilton

London

Toronto

Montreal

Québec

Saskatoon

Amiens Cedex 1 80

Grenoble

Lille

Nice

Paris

Pessac

Rouen

Toulouse Cedex 9 N/A

Berlin

Hamburg

Hanover

Kiel

Leipzig

Lÿneburg

Markkleeberg

Minden

München

Münster

Regensburg

Afula

Beersheba

Haifa

Jerusalem

Kfar Saba

Petah Tikva

Tel Aviv

Amersfoort

Amsterdam

Leiden

Maastricht

Rotterdam

Auckland

Christchurch

Barcelona

Córdoba

León

Madrid

Oviedo

Palma

Sabadell

Zaragoza

Bristol

Cambridge

Coventry

Edinburgh

Harrow

London

Manchester

Newcastle upon Tyne

Norwich

Nottinghamshirecc

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Centocor, Inc.

INDUSTRY

NCT00771667 - A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy | Biotech Hunter | Biotech Hunter