A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Approximately 170 juvenile patients will take part in the study worldwide. All patients will
receive 30mg/m2 (milligrams per meter squared, up to 50 mg per dose) of golimumab
subcutaneously (injection under the skin) every 4 weeks from Week 0 through Week 12. At Week
16, patients who have shown at least a 30 percent improvement in their signs and symptoms
from when they started the study will be randomized to receive either placebo (sham medicine
injection) or 30 mg/m2 of golimumab injections every 4 weeks from week 16 through week 48.
If a patient gets markedly worse and is receiving placebo injections, they will be restarted
on golimumab at the next scheduled visit and will continue on golimumab. Patients can leave
the study at any time without question. Between the Week 48 analyses timepoint to Week 144,
which is subsequently amended to Week 248, all patients will receive golimumab 30mg/meter
squared, unless, by measurements, they have been nearly cured (clinical remission) by being
on placebo, whereby they will be discontinued from the study. Patients may have a change in
background treatment after Week 48 based on therapeutic effect. Patients will continue
active treatment after Week 48 in a long-term extension until Week 144, which is
subsequently amended to Week 248. All patients will receive their fixed dose of commercial
methotrexate throughout the study duration. Safety will be monitored up to 152 week, which
is subsequently amended to 256 weeks including drawing blood and looking at laboratory
tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side
effects).

Inclusion Criteria:

- Diagnosis must have been before the patient's 16th birthday

- Disease duration of at least 6 months before study entry

- Must have 5 or more joints with active arthritis

- Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with
body surface area [BSA] 1.67 square meter or more must be taking a minimum of 15
mg/week of methotrexate)

- May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or
may take a stable dose of NSAIDS (non-steroidal anti-inflammatory drugs) 2 weeks
prior to entry

- Must have qualifying laboratory values at the first visit.

Exclusion Criteria:

- Have known allergies, hypersensitivity, or intolerance to golimumab or similar
therapeutics

- Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6
months after the last study agent administration

- Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study
initiation