Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis

Brief Summary: 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.

Detailed Summary: 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 244 weeks, wherein after Week 28, MTX dose change is allowed) and Follow-up Phase (8 weeks). The maximal study duration for a participant will not exceed 258 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.
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome:

• Serum Trough Concentration (C-trough) of Golimumab [ Time Frame: Week 28 ]
  The C-trough is the observed serum concentration immediately prior to the next administration of golimumab.
• Bayesian Area Under Curve at Steady State (AUCss) Over One Dosing Interval of 8 Weeks [ Time Frame: Weeks 0, 4, 8, 12, 20 and 28 ]
  The AUCss is defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).

Original Primary Outcome:

• Serum Trough Concentration (C-trough) of Golimumab [ Time Frame: Week 28 ]
  The C-trough is the observed serum concentration immediately prior to the next administration of golimumab.
• Bayesian Area Under Curve at Steady State (AUCss) Over One Dosing Interval of 8 Weeks [ Time Frame: Weeks 0, 4, 8, 12, 20, 28 and 52 ]
  The AUCss is defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).

Current Secondary Outcome:

• Serum Trough Concentration (C-trough) at Week 52 [ Time Frame: Week 52 ]
  The C-trough is the observed serum concentration immediately prior to the next administration of golimumab.
• Baysesian Area Under Curve at Steady State (AUCss) at Week 52 [ Time Frame: Week 52 ]
  The AUCss is defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).

Original Secondary Outcome: Same as current

Information By: Janssen Research & Development, LLC

Dates:
Date Received: October 27, 2014
Date Started: December 22, 2014
Date Completion: February 21, 2023
Last Updated: May 16, 2017
Last Verified: May 2017