A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

PHASE3CompletedINTERVENTIONAL
Enrollment

640

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

August 31, 2014

Study Completion Date

October 31, 2014

Conditions
Crohn's DiseaseInflammatory Bowel DiseaseIBDColitis
Interventions
DRUG

Group 1: Placebo

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

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).

Trial Locations (220)

Unknown

Tucson

Little Rock

La Jolla

Los Angeles

San Diego

Santa Monica

Torrance

Lone Tree

Boca Raton

Gainesville

Jacksonville

Largo

Miami

Naples

Port Orange

Winter Park

Athens

Atlanta

Decatur

Macon

Idaho Falls

Chicago

Clive

Pratt

Topeka

Crestview Hills

Lexington

Louisville

Baton Rouge

Houma

New Orleans

Chevy Chase

Columbia

Towson

Boston

Worcester

Ann Arbor

Chesterfield

Novi

Troy

Ypsilanti

Rochester

Jackson

Ocean Springs

Columbia

Kansas City

Lees Summit

Urbana

Las Vegas

Egg Harbor

Marlton

Morristown

Great Neck

New York

Poughkeepsie

Chapel Hill

Charlotte

Raleigh

Beavercreek

Cincinnati

Columbus

Mentor

Norman

Oklahoma City

Tulsa

Bend

Portland

Malvern

Philadelphia

Columbia

North Charleston

Germantown

Nashville

Austin

Grapevine

Houston

Tyler

Salt Lake City

Charlottesville

Chesapeake

Virginia Beach

Bellevue

Seattle

Madison

Adelaide

Cairns

Central Queensland M C

Concord

Fremantle

Garran

Liverpool

Malvern

Parkville

Brussels

Leuven

Goiânia

Porto Alegre

Rio de Janeiro

São Paulo

Pleven

Rousse

Sofia

Varna

Calgary

Edmonton

Vancouver

Brandon

Kingston

London

Toronto

Montreal

Saskatoon

Saskatoon

Winnipeg

Osijek

Rijeka

Zagreb

Amiens

Bordeaux

Caen

Lille

Paris

Rouen

Vandœuvre-lès-Nancy

Berlin

Bochum

Frankfurt

Halle

Hamburg

Hanover

Haßloch

Heidelberg

Kiel

Lÿneburg

Mannheim

Minden

München

Münster

Regensburg

Stade

Ulm

Békéscsaba

Budapest

Debrecen

Gyula

Mosonmagyaróvár

Pécs

Szekszárd

Székesfehérvár

Reykjavik

Beer Yaakov

Haifa

Jerusalem

Kfar Saba

Petah Tikva

Rehovot

Tel Aviv

Chikushino-shi

Hachiōji

Hamamatsu

Hirosaki

Hiroshima

Kagoshima

Nishinomiya

Ohtsu

Osaka

Ōita

Sakura

Sapporo

Sendai

Suita-Shi

Tokyo

Tsu

Uruma

Yokkaichi

Yokohama

Yokosuka

Amsterdam

Amsterdam-Zuidoost

Maastricht

Rotterdam

Auckland

Christchurch

Dunedin

Grafton

Hamilton

Hastings

Plenty

Wellington

Bydgoszcz

Elblag

Krakow

Lodz

Warsaw

Moscow

Novosibirsk

Belgrade

Cape Town

Durban

Pretoria

Daegu

Gyeonggi-do

Seoul

Madrid

Sabadell

Santiago de Compostela

Birmingham

Brighton

Bristol

Cambridge

Gloucester

Harrow

Liverpool

London

Manchester

Norwich

Nottinghamshirecc

Oxford

Shrewsbury

Southampton

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01369342 - A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2) | Biotech Hunter | Biotech Hunter