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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,282

Participants

Timeline

Start Date

September 13, 2011

Primary Completion Date

June 10, 2015

Study Completion Date

October 1, 2019

Conditions
Crohn's DiseaseColitisIBDInflammatory Bowel Disease
Interventions
DRUG

Placebo SC

Placebo will be administered subcutaneously.

DRUG

Placebo IV

Placebo will be administered as a single Intravenous infusion at week 0.

DRUG

Ustekinumab 90 mg SC q8w

Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.

DRUG

Ustekinumab 130 mg IV

Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.

DRUG

Ustekinumab 90 mg SC q12w

Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.

Trial Locations (220)

Unknown

Tucson

La Jolla

Los Angeles

San Carlos

San Diego

Santa Monica

Lone Tree

New Haven

Boca Raton

Gainesville

Jacksonville

Naples

Weston

Winter Park

Atlanta

Decatur

Macon

Idaho Falls

Chicago

Evanston

Clive

Pratt

Crestview Hills

Lexington

Louisville

Baton Rouge

New Orleans

Baltimore

Chevy Chase

Towson

Boston

Worcester

Ann Arbor

Chesterfield

Detroit

Troy

Ypsilanti

Rochester

Jackson

Ocean Springs

Columbia

Lee's Summit

Urbana

Las Vegas

Lebanon

Marlton

Great Neck

New York

Poughkeepsie

Rochester

Chapel Hill

Charlotte

Raleigh

Cincinnati

Cleveland

Columbus

Mentor

Oklahoma City

Bend

Portland

Hershey

Philadelphia

Pittsburgh

Charleston

Columbia

North Charleston

Nashville

Austin

Grapevine

Houston

Tyler

Salt Lake City

Charlottesville

Chesapeake

Virginia Beach

Seattle

Madison

Adelaide

Bedford Park

Box Hill

Central Queensland M C

Concord

Garran

Liverpool

Malvern

Parkville

Innsbruck

Vienna

Brussels

Leuven

Liège

Goiânia

Porto Alegre

Rio de Janeiro

São Paulo

Pleven

Rousse

Sofia

Varna

Calgary

Edmonton

Vancouver

Brandon

Winnipeg

Hamilton

Kingston

London

Toronto

Montreal

Saskatoon

Rijeka

Zagreb

Hradec Králové

Ústí nad Labem

Herlev

Silkeborg

Lille

Marseille

Paris

Pessac

Reims

Rouen

Toulouse

Vandœuvre-lès-Nancy

Berlin

Erlangen

Frankfurt

Freiburg im Breisgau

Halle

Hamburg

Hanover

Haßloch

Heidelberg

Jena

Kiel

LÿNEBURG

Mannheim

München

Münster

Regensburg

Stade

Ulm

Békéscsaba

Budapest

Debrecen

Mosonmagyaróvár

Pécs

Szeksz Rd N/a

Székesfehérvár

Reykjavik

Dublin

Jerusalem

Kfar Saba

Petah Tikva

Ramat Gan

Rehovot

Tel Aviv

Tzrifin

Chikushino-shi

Fukuoka

Hachiōji

Hamamatsu

Hirosaki

Hiroshima

Kagoshima

Nishinomiya

Ohtsu

Osaka

Ōita

Sakura

Sapporo

Sendai

Suita-shi

Tokyo

Tsu

Uruma

Yokkaichi

Yokohama

Yokosuka

Amsterdam

Maastricht

Rotterdam

Auckland

Christchurch

Dunedin

Grafton

Hamilton

Hastings

Plenty

Elblag

Krakow

Lodz

Warsaw

Moscow

Novosibirsk

Saint Petersburg

Belgrade

Cape Town

Cape Town Western Cape

Pretoria

Somerset West

Daegu

Gyeonggi-do

Seoul

Madrid

Birmingham

Brighton

Bristol

Cambridge

Cardiff

Exeter

Gloucester

Liverpool

London

Manchester

Norwich

Nottinghamshirecc

Oxford

Shropshire

Southampton

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01369355 - A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) | Biotech Hunter | Biotech Hunter