The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA) manifested by greater than or equal to (\>=) 5 joints with active arthritis despite methotrexate (MTX) therapy for \>= 2 months.
This is a single arm, Open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study) study to determine the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), efficacy (effectiveness) and safety of intravenous golimumab in participants with pJIA despite current treatment with methotrexate (MTX). The study will consist of 3 parts: Screening Phase (6 weeks); an Open-label Treatment Phase (consists of golimumab and MTX treatment for 52 weeks, wherein after Week 28, MTX dose change is allowed); Long-term Extension Phase (after Week 52 through Week 252) and Extended Treatment Period (after week 252). The maximal study duration for a participant will not exceed 832 weeks. All the eligible participants will be administered golimumab IV infusion and commercial MTX. Blood samples will be collected for evaluation of pharmacokinetics of study treatment. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
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.
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.
Unnamed facility
San Diego, California, United States
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Chicago, Illinois, United States
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Boston, Massachusetts, United States
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Hackensack, New Jersey, United States
Unnamed facility
New Hyde Park, New York, United States
Unnamed facility
Durham, North Carolina, United States
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Hickory, North Carolina, United States
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Avon, Ohio, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Cleveland, Ohio, United States
...and 28 more locations
Serum Trough Concentration (C-trough) of Golimumab
Serum golimumab trough concentration at Week 28 was reported.
Time frame: Week 28
Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28
AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
Time frame: Week 28
Serum Trough Concentration (C-trough) at Week 52
Serum golimumab trough concentration at Week 52 was reported.
Time frame: Week 52
Baysesian Area Under Curve at Steady State (AUCss) at Week 52
AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
Time frame: Week 52
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