Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

PHASE3CompletedINTERVENTIONAL
Enrollment

1,820

Participants

Timeline

Start Date

August 7, 2013

Primary Completion Date

April 30, 2018

Study Completion Date

April 30, 2018

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

Sirukumab 100 mg

Sirukumab 100 mg subcutaneously (SC) at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 2, and every 2 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.

DRUG

Sirukumab 50 mg

Sirukumab 50 mg SC at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 4, and every 4 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.

DRUG

Placebo

Between sirukumab 50 mg injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks until the study becomes open-label, and placebo injections are discontinued.

Trial Locations (197)

Unknown

Birmingham

Glendale

Mesa

Peoria

Phoenix

Covina

El Cajon

Glendale

Hemet

Huntington Beach

La Jolla

La Palma

Placentia

Upland

Victorville

Whittier

Hamden

Aventura

Boca Raton

Brandon

Daytona Beach

DeBary

Miami

Orlando

Palm Harbor

Plantation

Sarasota

Tampa

Zephyrhills

Cedar Rapids

Bowling Green

Monroe

Cumberland

Hagerstown

Wheaton

Rochester

Flowood

Springfield

St Louis

Omaha

Las Vegas

Freehold

Albuquerque

Brooklyn

Charlotte

Cincinnati

Columbus

Dayton

Middleburg Heights

Edmond

Tulsa

Duncansville

Wyomissing

Charleston

Austin

Carrollton

Corpus Christi

Cypress

Dallas

Houston

Katy

Lubbock

Mesquite

Victoria

Beckley

Clarksburg

Buenos Aires

Rosario

San Miguel de Tucumán

Victoria Park

Vienna

Liège

Plovdiv

Sofia

Victoria

Winnipeg

Edmonton

Rancagua

Santiago

Valdivia

Bogotá

Chía

Medellín

Osijek

Rijeka

Zagreb

Toulouse

Berlin

Cologne

Frankfurt am Main

Göttingen

Hamburg

Vogelsang-Gommern

Würzburg

Ayauta

Bunkyō City

Fukuoka

Higashihiroshima

Hiroshima

Izumo

Kagoshima

Katō

Kawagoe

Kita-Gun

Kumamoto

Kurume

Matsuyama

Miyazaki

Nagano

Nagasaki

Nagoya

Nishimuro-gun

Nishinomiya

Okayama

Osaka

Sapporo

Sasebo

Shibata

Shimonoseki

Shimotsuke

Shinjuku-ku

Sumida-ku

Takaoka,Toyama

Takasaki

Tokorozawa

Tokushima

Tomishiro

Tonami

Tsu

Ureshino

Yokohama

Alytus

Kaunas

Klaipėda

Šiauliai

Kuala Lumpur

Kuching

Cuernavaca

Guadalajara

Mexicali

Mérida

México

Morelia

San Luis de Potosi

Sneek

Bialystok

Bydgoszcz

Elblag

Lublin

Poznan

Ustroń

Warsaw

Lisbon

San Juan

Bucharest

Iași

Barnaul

Moscow

Novosibirsk

Omsk

Orenburg

Ryazan

Saint Petersburg

Saratov

Smolensk

Ulyanovsk

Yaroslavl

Belgrade

Kragujevac

Niška Banja

Cape Town

Port Elizabeth

Pretoria

Busan

Daegu

Daejeon

Gwangju

Incheon

Jeonju

Namdong-Gu

Seongnam-si

Seoul

Suwon

A Coruña

Barakaldo

Santander

Santiago de Compostela

Kaohsiung City

Taichung

Taipei

Kharkiv

Kyiv

Odesa

Vinnytsia

Zaporizhzhia

London

Wigan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY

NCT01856309 - Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | Biotech Hunter | Biotech Hunter