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
Condition: Arthritis, Juvenile
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Golimumab; Methotrexate
Intervention description: 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.
Intervention MeSH terms: Golimumab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Methotrexate; Anti-TNFα Antibody; Golimumab; Pediatric Participants

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.
    

Eligibility criteria:

        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