An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

1,228

Participants

Timeline

Start Date

September 30, 2007

Primary Completion Date

October 31, 2011

Study Completion Date

February 28, 2015

Conditions
Colitis, Ulcerative
Interventions
BIOLOGICAL

Placebo

Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).

BIOLOGICAL

Golimumab 50 mg

Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).

BIOLOGICAL

Golimumab 100 mg

Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.

BIOLOGICAL

Golimumab 200 mg

Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.

Trial Locations (297)

Unknown

Birmingham

Little Rock

Anaheim

Merced

Orange

Roseville

San Diego

Lakewood

Littleton

Bristol

Newark

Boca Raton

Gainesville

Hialeah

Hollywood

Jacksonville

Naples

New Port Richey

North Miami Beach

Port Orange

Tampa

Winter Park

Zephyrhills

Atlanta

Decatur

Savannah

Snellville

Arlington Heights

Chicago

Clive

Fort Dodge

Pratt

Topeka

Lexington

Louisville

Monroe

Hagerstown

Hollywood

Laurel

Worcester

Ann Arbor

Dearborn

Troy

Plymouth

Rochester

Pascagoula

Tupelo

Urbana

Las Vegas

Lebanon

Egg Harbor

Great Neck

Huntington

New York

Rochester

Asheville

Boone

Charlotte

Harrisburg

Kinston

Morganton

New Bern

Raleigh

Wilmington

Winston-Salem

Fargo

Cincinnati

Cleveland

Colombus

Norman

Oklahoma City

Tulsa

Portland

Limerick

Philadelphia

Charleston

Columbia

Germantown

Nashville

Austin

Dallas

Galveston

Houston

Logan

Ogden

Burlington

Chesapeake

Christiansburg

Fairfax

Richmond

Bellevue

Seattle

Spokane

Tacoma

Madison

Milwaukee

Adelaide

Bankstown

Box Hill

Brisbane

Cairns

Fitzroy

Fremantle

Herston

Launceston

Malvern

Parkville

Prahran

Westmead

Innsbruck

Vienna

Bonheiden

Brussels

Ghent

Leuven

Liège

Roeselare

Bulgaria

Pleven

Plovdiv

Rousse

Sofia

Calgary

Vancouver

Victoria

Winnipeg

Barrie

Chatham

Hamilton

Kingston

London

Vaughan

Montreal

Québec

Saskatoon

Toronto

Windsor

Èeské Budìjovice 1

Hradec Králové

Litoměřice

Ostrava

Aalborg

Aarhus C

Hvidovre

Odense C

Amiens Cedex 1 80

Bordeaux

Clichy

Lille

Marseille

Nice

Paris

Rouen

Aachen

Berlin

Berlin Be

Bochum

Frankfurt

Hamburg

Hanover

Heidelberg

Herne

Jena

Kiel

Magdeburg

Minden

München

Münster

Neustadt

Stade

Balatonfüred

Budapest

Debrecen

Dunaújváros

Gyõr

Gyula

Gyulai Ut 18

Miskolc

Mosonmagyaróvár

Pécs

Siófok

Sopron

Szeged

Szekszárd

Székesfehérvár

Szombathely

Veszprém

Zalaegerszeg

Bangalore

Chennai

Hyderabad

Hyderabad Andh Prad

Jaipur

Kārnād

Lucknow Gpo

Ludhiana

New Delhi

Pune

Vishakapatanam

Afula

Beer Yaakov

Beersheba

Haifa

Hedera

Jerusalem

Kfar Saba

Kiryat Bialik

Nazareth

Petah-Tikv

Rehovot

Tel Aviv

Tel Litwinsky

Bunkyō City

Chikushinoshi

Fukuoka

Hiroshima

Kagoshima

Kurashiki

Kurume

Nagoya

Nishinomiya

Okayama

Osaka

Sakura

Sapporo

Tokyo

Yokkaichi

Balvi

Daugavpils

Riga

Kaunas

Klaipėda

Šiauliai

Vilnius

Vilnius Lt

Amsterdam

Ede Gld

Groningen

Leiden

Nieuwegein

Rotterdam

Auckland

Christchurch

Dunedin

Hamilton

Hastings

Bialystok

Bydgoszcz

Częstochowa

Elblag

Gdansk

Krakow

Lodz

Lublin

Opole

Skierniewice

Sopot

Szczecin

Torun

Warsaw

Bucharest

Cluj-Napoca

Iași

Târgu Mureş

Timișoara

Moscow

Novosibirsk

Omsk

Saint Petersburg

Smolensk

Yaroslavl

Belgrade

Niš

Zemun

Bratislava

Martin

Nitra

Nové Mesto nad Váhom

Prešov

Trnava

Cape Town

Cape Town West Cape

Durban

Plumstead West Cape

Pretoria Gauteng

Gothenburg

Stockholm

Donetsk

Ivano

Kharkiv

Kiev

Kyiv

Lviv

Poltava

Simferopol

Vinnitsa

Zhaporozhia 69104

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY

NCT00488631 - An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis | Biotech Hunter | Biotech Hunter