A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)

PHASE3CompletedINTERVENTIONAL
Enrollment

769

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

July 31, 2013

Conditions
Crohn's DiseaseIBDColitisInflammatory Bowel Disease
Interventions
DRUG

Group 2 ustekinumab 130 mg

Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.

DRUG

Group 3: ustekinumab approximately 6 mg/kg

Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg), 390 mg (weight \> 55 kg and \<= 85 kg), and 520 mg (weight \> 85 kg).

DRUG

Group 1: Placebo

Form=solution for injection, route=intravenous use, in a single dose.

Trial Locations (175)

Unknown

Tucson

Little Rock

La Jolla

Los Angeles

Redwood City

San Carlos

San Diego

Lone Tree

New Haven

Gainesville

Jacksonville

Weston

Winter Park

Atlanta

Decatur

Macon

Chicago

Evanston

Clive

Lexington

Louisville

Baton Rouge

New Orleans

Baltimore

Chevy Chase

Towson

Boston

Worcester

Ann Arbor

Chesterfield

Novi

Troy

Rochester

Ocean Springs

Lees Summit

Urbana

Las Vegas

Lebanon

Marlton

Morristown

Great Neck

New York

Rochester

Chapel Hill

Charlotte

Raleigh

Beavercreek

Cincinnati

Cleveland

Oklahoma City

Bend

Springfield

Hershey

Philadelphia

Pittsburgh

North Charleston

Nashville

Austin

Houston

Tyler

Salt Lake City

Charlottesville

Chesapeake

Norfolk

Virginia Beach

Seattle

Madison

Bedford Park

Box Hill

Central Queensland M C

Concord

Garran

Liverpool

Malvern

Parkville

Innsbruck

Sankt Pölten

Vienna

Brussels

Leuven

Liège

Rio de Janeiro

Calgary

Edmonton

Vancouver

Brandon

Winnipeg

Hamilton

Kingston

London

Montreal

Hradec Králové

Ústí nad Labem

Herlev

Silkeborg

Amiens

Caen

Lille

Marseille

Nantes

Paris

Pessac

Reims

Rouen

Toulouse

Berlin

Erlangen

Essen

Frankfurt

Freiburg im Breisgau

Halle

Hamburg

Hanover

Heidelberg

Jena

Kiel

Lÿneburg

Mannheim

Minden

München

Münster

Regensburg

Tübingen

Ulm

Szekszárd

Akureyri

Reykjavik

Dublin

Jerusalem

Tel Litwinsky

Chikushino-shi

Fukuoka

Hamamatsu

Kagoshima

Nishinomiya

Ohtsu

Osaka

Ōita

Sakura

Sapporo

Tokyo

Yokkaichi

Amsterdam

Maastricht

Rotterdam

Auckland

Christchurch

Grafton

Hamilton

Krakow

Lodz

Belgrade

Niš

Cape Town

Overport

Seoul

Madrid

Sagunto

Birmingham

Brighton

Bristol

Cambridge

Cardiff

Exeter

Gloucester

Harrow

Liverpool

London

Manchester

Norwich

Nottinghamshirecc

Oxford

Shropshire

South Shields

Southampton

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01369329 - A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1) | Biotech Hunter | Biotech Hunter