A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,670

Participants

Timeline

Start Date

August 15, 2012

Primary Completion Date

September 2, 2015

Study Completion Date

December 6, 2016

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

Placebo

Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 50.

DRUG

Placebo

Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 104.

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 52 through Week 104.

DRUG

Sirukumab

Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 104.

DRUG

Sirukumab

Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 104.

Trial Locations (156)

Unknown

Glendale

Mesa

Peoria

Phoenix

Covina

El Cajon

Glendale

Hemet

Huntington Beach

La Jolla

La Palma

Whittier

Aventura

Brandon

Daytona Beach

Lake Mary

Naples

Palm Harbor

Tampa

Zephyrhills

Indianapolis

Cedar Rapids

Bowling Green

Monroe

Wheaton

Eagan

Springfield

St Louis

Omaha

Albuquerque

Brooklyn

Plainview

Charlotte

Cincinnati

Middleburg Heights

Edmond

Tulsa

Duncansville

Wyomissing

Carrollton

Corpus Christi

Dallas

Houston

Lubbock

Mesquite

Kennewick

Beckley

Clarksburg

Plovdiv

Sofia

Victoria

Winnipeg

Ottawa

Burlington

Edmonton

Rancagua

Santiago

Valdivia

Bogotá

Chía

Medellín

Osijek

Rijeka

Zagreb

Ayauta-Gun

Bunkyō City

Fukuoka

Higashihiroshima

Izumo

Kagoshima

Katō

Kawagoe

Kita-Gun

Kumamoto

Kurume

Miyazaki

Nagano

Nagasaki

Nagoya

Osaka

Sapporo

Sasebo

Shimonoseki

Shimotsuke

Shinjuku-Ku

Sumida-Ku

Takaoka,Toyama

Takasaki

Tokorozawa

Tokushima

Tomishiro

Tsu

Ureshino

Yokohama

Alytus

Kaunas

Klaipėda

Šiauliai

Kuala Lumpur

Kuching

Cuernavaca

Guadalajara

Juárez

Mexicali

Mexico City

Mérida

México

Morelia

San Luis de Potosi

Bialystok

Bydgoszcz

Elblag

Lublin

Poznan

Ustroń

Warsaw

Bucharest

Cluj-Napoca

Iași

Kemerovo

Moscow

Novosibirsk

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

Kaohsiung City

Taichung

Taipei

Donetsk

Kharkiv

Kiev

Kyiv

Odesa

Sympheropol

Vinnytsia

Zaporizhzhia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY

NCT01604343 - A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D) | Biotech Hunter | Biotech Hunter