A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

December 22, 2014

Primary Completion Date

July 9, 2018

Study Completion Date

September 27, 2024

Conditions
Arthritis, Juvenile
Interventions
DRUG

Golimumab

Golimumab 80 mg/m\^2 IV infusion at Weeks 0, 4, and every 8 weeks through Week 244. At Week 252, participants who meet the criteria for the optional Extended Treatment Period (ETP) may continue treatment with golimumab 80 mg/m\^2 every 8 weeks after completion of the Week 252 assessments.

DRUG

Methotrexate

Methotrexate BSA-based dose (10 to 30 mg/m\^2 per week for participants with BSA \<1.67 m\^2, or minimum of 15 mg/week for participants with BSA \>=1.67 m\^2) weekly at least through Week 28.

Trial Locations (38)

Unknown

San Diego

Chicago

Boston

Hackensack

New Hyde Park

Durham

Hickory

Avon

Cincinnati

Cleveland

Portland

Philadelphia

Austin

Salt Lake City

Buenos Aires

Rosario

San Miguel de Tucumán

Botucatu

Campinas

Porto Alegre

Rio de Janeiro

São Paulo

Calgary

Toronto

Montreal

Región Metropolitana de Santia

Haifa

Kfar Saba

Petah Tikva

Chihuahua City

Guadalajara

Mexico City

Mosco2

Saint Petersburg

Saratov

Tolyatti

Ufa

Cape Town

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02277444 - A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy | Biotech Hunter | Biotech Hunter