A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

PHASE3TerminatedINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

September 30, 2013

Study Completion Date

May 31, 2014

Conditions
Juvenile Idiopathic Arthritis
Interventions
DRUG

CNTO 148 (Golimumab)

Patients will receive subcutaneous (SC) (under the skin) injection of golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 248.

DRUG

Placebo

Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive SC injection of placebo every 4 weeks from Week 16 through Week 48.

DRUG

Methotrexate

All patients will receive their fixed dose of commercial methotrexate (10 to 30 mg per square meter) weekly throughout the study duration.

Trial Locations (35)

Unknown

Los Angeles

San Francisco

Augusta

Boston

Durham

Cincinnati

Portland

Bregenz

Vienna

Brussels

Ghent

Leuven

Botucatu

Curitiba

Ribeirão Preto

Rio de Janeiro

Halifax

Toronto

Helsinki

Oulu

Bad Bramstedt

Berlin

Bremen

Hamburg

Sankt Augustin

Vilnius

Mexico City

Monterrey

San Luis Potosí City

Utrecht

Krakow

Lodz

Moscow

Saint Petersburg

Samara

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Schering-Plough

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY