Research study to evaluate the safety and effectiveness of an investigational drug is currently being conducted in children diagnosed with polyarticular juvenile rheumatoid arthritis with active disease while receiving methotrexate therapy. Aim of the international study is to evaluate the efficacy and safety of the drug in patients with active JRA/JIA who are receiving methotrexate therapy. Study is being conducted in Belgium, Canada, Finland, France, Germany, Italy, the Netherlands, Spain, Sweden, Switzerland, United Kingdom, and USA.

Ages Eligible for Study:  4 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

To be eligible for the trial, patients must meet all of the following criteria:

• Been diagnosed with juvenile rheumatoid arthritis (JRA) for at least 6 months prior to study entry.
• Be at least 4 years of age, but less than 18 years of age with onset of disease before age 16.
• Must be receiving a stable methotrexate (MTX) therapy at least 3 months before trial entry. If using oral corticosteroids, must have been on a stable dose for at least 4 weeks. If using NSAIDs, patients should be on a stable dose for at least 4 weeks
• The patient's parent must be capable and willing of giving informed consent, and, if appropriate for the patient's age, the patient must be capable of giving assent for study participation.

Exclusion Criteria

Patients who meet any of the following criteria may not be enrolled in the study:

• Are incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for age-appropriate self care.
• Are pregnant, nursing, or planning a pregnancy within 18 months of enrollment.
• Have a rheumatic disease other than JRA or have a history of known demyelinating diseases such as multiple sclerosis.
• Have been previously treated with infliximab or any other therapeutic agent targeted at reducing TNF, including, but not limited to, REMICADE, etanercept, pentoxifylline, D2E7, CDP870, or thalidomide.
• Have received DMARDs other than MTX therapy within last 4 weeks
• Have had a serious infection during the previous 2 months or have a history of or ongoing chronic or recurrent infectious disease.
• Have a history of known infection with human immunodeficiency virus (HIV) or have a current active hepatitis B or a known history of hepatitis C infection.