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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified September 2025 by Janssen Research & Development, LLC
Sponsor
Janssen Research & Development, LLC
Information Provided by (Responsible Party)
Janssen Research & Development, LLC
Clinicaltrials.gov Identifier
NCT02277444
Other Study ID Numbers:
CR105178
First Submitted
October 26, 2014
First Posted
October 28, 2014
Results First Posted
October 26, 2020
Last Update Posted
November 13, 2025
Last Verified
September 2025

ClinicalTrials.gov processed this data on October 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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.

Condition or DiseaseIntervention/Treatment
Arthritis, Juvenile
Drug: Golimumab

Study Design

Study TypeInterventional
Actual Enrollment130 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
Study Start DateDecember 21, 2014
Actual Primary Completion DateJuly 8, 2018
Actual Study Completion DateSeptember 26, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
Golimumab + Methotrexate
Participants will receive 80 milligram per meter square (mg/m\^2) as an intravenous (IV) infusion at Weeks 0, 4, and every 8 weeks thereafter up to Week 244, along with commercial methotrexate (MTX) weekly through Week 28 at the same Body Surface Area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square (m\^2), or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at the time of study entry. 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: 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.

Outcome Measures

Primary Outcome Measures
  1. Serum Trough Concentration (C-trough) of Golimumab
    Serum golimumab trough concentration at Week 28 was reported.
  2. 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).
Secondary Outcome Measures
  1. Serum Trough Concentration (C-trough) at Week 52
    Serum golimumab trough concentration at Week 52 was reported.
  2. 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).

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Diagnosis must be made per Juvenile Idiopathic Arthritis (JIA) International League of Associations for Rheumatology (ILAR) diagnostic criteria and the onset of disease must have been before the participant's 16th birthday
Failure or inadequate response to at least a 2 month course of methotrexate (MTX) before screening
Participants must have greater than or equal to (\>=) 5 joints with active arthritis at screening and at Week 0 as defined by American College of Rheumatology (ACR) criteria (that is, a joint with either swelling, or in the absence of swelling, limited range of motion associated with pain on motion or tenderness)
Participants must have a screening C-reactive protein (CRP) of \>=0.1 milligram (mg)/deciliter (dL) with the exception of approximately 30 percent (%) of the study population
Participants must have active polyarticular juvenile idiopathic arthritis (pJIA) despite current use of oral, intramuscular, or subcutaneous MTX for \>=2 months before screening. For participants with body surface area (BSA) less than (\<)1.67 meter square (m\^2), the MTX dose must be between 10 to 30 milligram per meter square (mg/m\^2) per week and stable for \>=4 weeks before screening. For participants with BSA \>=1.67 m\^2, the MTX dose must be a minimum of 15 mg/week and must be stable for \>=4 weeks before screening. In situations where there is documented intolerance of doses greater than (\>)10 mg/m\^2 weekly (for participants with BSA \<1.67 m\^2) or \>=15 mg/week (for participants with BSA \>=1.67 m\^2); or where documented country or site regulations prohibit use of \>=15 mg of MTX per week in participants with BSA \>=1.67 m\^2, participants may be entered into the trial on a lower dose of MTX
Exclusion Criteria
Participant has initiated disease-modifying antirheumatic drugs (DMARDs) and/or immunosuppressive therapy within 4 weeks prior to first study agent administration
Participant has been treated with intra-articular, intramuscular or intravenous corticosteroids (including intramuscular corticotropin) during the 4 weeks before first study agent administration
Participant has been treated with any therapeutic agent targeted at reducing Interleukin (IL)-12 or IL 23, including but not limited to ustekinumab and ABT-874, within 3 months before first study agent administration
Participant has been treated with natalizumab, efalizumab, or therapeutic agents that deplete B or T cells (eg, rituximab, alemtuzumab, or visilizumab) during the 12 months before first study agent administration, or have evidence at screening of persistent depletion of the targeted lymphocyte after receiving any of these agents
Participant has been treated with alefacept within 3 months before first study agent administration
If a participant has been previously treated with an anti-tumor necrosis factor alpha (TNF alpha) agent, the reason for discontinuation of the anti-TNF alpha agent cannot have been a severe or serious adverse event consistent with the class of anti-TNF alpha agents

Contacts and Locations

Sponsors and CollaboratorsJanssen Research & Development, LLC
Locations
| San Diego California, United States, | Chicago Illinois, United States, | Boston Massachusetts, United States, | Hackensack New Jersey, United States, | New Hyde Park New York, United States, | Durham North Carolina, United States, | Hickory North Carolina, United States, | Avon Ohio, United States, | Cincinnati Ohio, United States, | Cleveland Ohio, United States, | Portland Oregon, United States, | Philadelphia Pennsylvania, United States, | Austin Texas, United States, | Salt Lake City Utah, United States, | Buenos Aires , Argentina, | Rosario , Argentina, | San Miguel de Tucumán , Argentina, | Botucatu , Brazil, | Campinas , Brazil, | Porto Alegre , Brazil, | Rio de Janeiro , Brazil, | São Paulo , Brazil, | Calgary Alberta, Canada, | Toronto Ontario, Canada, | Montreal Quebec, Canada, | Región Metropolitana de Santia , Chile, | Haifa , Israel, | Kfar Saba , Israel, | Petah Tikva , Israel, | Chihuahua City , Mexico, | Guadalajara , Mexico, | Mexico City , Mexico, | Mosco2 , Russia, | Saint Petersburg , Russia, | Saratov , Russia, | Tolyatti , Russia, | Ufa , Russia, | Cape Town , South Africa,
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full Text)
Documents provided by Janssen Research & Development, LLC: Study Protocol  April 16, 2020Documents provided by Janssen Research & Development, LLC: Statistical Analysis Plan  July 31, 2018