A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

274

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

May 31, 2014

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

Placebo + methotrexate (MTX) (Group 1)

Placebo: form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

DRUG

Ustekinumab + MTX (Group 2)

Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

DRUG

Ustekinumab + MTX (Group 3)

Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose)

DRUG

CNTO 1959 + MTX (Group 4)

CNTO 1959: type = exact number, unit = mg, number = 200, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

DRUG

CNTO 1959 + MTX (Group 5)

CNTO 1959: type = exact number, unit = mg, number = 50, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose)

Trial Locations (47)

Unknown

Palm Harbor

Rock Island

St Louis

Buenos Aires

San Juan

San Miguel de Tucumán

Plovdiv

Sofia

Osorno

Bogotá

Bucaramanga

Chía

Medellín

Santiago de Cali

Hlučín

Kladno

Uherské Hradiště

Budapest

Gödöllő

Székesfehérvár

Szombathely

Veszprém

Bialystok

Elblag

Krakow

Poznan

Sopot

Sosnowiec

Warsaw

Kazan'

Moscow

Novosibirsk

Petrozavodsk

Saint Petersburg

Saratov

Ufa

Ulyanovsk

Yaroslavl

Singapore

Donetsk

Ivano-Frankivsk

Kharkiv

Kiev

Simferopol

Ternopil

Uzhhorod

Vinnitsa

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01645280 - A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy | Biotech Hunter | Biotech Hunter