A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)

PHASE3CompletedINTERVENTIONAL
Enrollment

878

Participants

Timeline

Start Date

August 6, 2012

Primary Completion Date

March 17, 2015

Study Completion Date

January 12, 2016

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

Placebo

Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 22.

DRUG

Placebo

Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 52.

DRUG

Sirukumab

Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 23 through Week 52.

DRUG

Sirukumab

Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 52.

DRUG

Sirukumab

Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 52.

Trial Locations (201)

Unknown

Birmingham

Glendale

Mesa

Phoenix

Covina

El Cajon

Hemet

Huntington Beach

La Jolla

La Palma

Placentia

Santa Monica

Tustin

Upland

Victorville

Whittier

Hamden

Aventura

Boca Raton

Brandon

Daytona Beach

Lake Mary

Miami

Naples

Orlando

Palm Harbor

Plantation

Sarasota

Tampa

Zephyrhills

Boise

Idaho Falls

Indianapolis

Cedar Rapids

Bowling Green

Monroe

Shreveport

Cumberland

Frederick

Hagerstown

Eagan

Rochester

Flowood

Tupelo

Springfield

St Louis

Omaha

Las Vegas

Freehold

Albuquerque

Brooklyn

Lake Success

Plainview

Charlotte

Hickory

Cincinnati

Columbus

Dayton

Middleburg Heights

Edmond

Tulsa

Erie

Pittsburgh

Wyomissing

East Greenwich

Charleston

Austin

Carrollton

Corpus Christi

Cypress

Dallas

Houston

Katy

Lubbock

Mesquite

Richmond

Victoria

Kennewick

Seattle

Beckley

Clarksburg

Buenos Aires

Rosario

San Miguel de Tucumán

Campbelltown

Victoria Park

Vienna

Liège

Victoria

Winnipeg

St. John's

Kitchener

Burlington

St. John's

Toronto

Zagreb

Paris

Toulouse

Berlin

Cologne

Dresden

Erfurt

Frankfurt am Main

Gÿttingen N/A

Hamburg

Herne

Kiel Kronshagen

Schwerin

Vogelsang-Gommern

Würzburg

Zerbst

Ayauta

Bunkyō City

Fukuoka

Fukuyama

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

Tomakomai

Tomishiro

Tonami

Tsu

Ureshino

Yokohama

Kaunas

Klaipėda

Guadalajara

Mérida

San Luis Potosí City

Sneek

Christchurch

Hamilton

Wellington

Bydgoszcz

Elblag

Lublin

Poznan

Ustroń

Warsaw

Coimbra

Lisbon

San Juan

Barnaul

Moscow

Novosibirsk

Omsk

Orenburg

Ryazan

Saint Petersburg

Saratov

Ulyanovsk

Busan

Daegu

Daejeon

Gwangju

Incheon

Jeonju

Seongnam-si

Seoul

Suwon

A Coruña

Bilbao

Madrid

Mérida

San Cristóbal de La Laguna

Santander

Santiago de Compostela

Kaohsiung City

Taichung

Taipei

Barnsley

London

Middlesbrough

Sheffield

Wigan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY