Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis

Inclusion Criteria

• Diagnosis of active poly-JIA as determined by International League of Associations for Rheumatology (ILAR) criteria
• Onset of signs and symptoms of poly-JIA for 12 months or less prior to study screening
• Willing to use acceptable forms of contraception for the duration of the study and for 3 months after the study
• Parent or guardian willing to provide informed consent
• Able to attend all study visits

Exclusion Criteria

• Received or currently receiving disease-modifying antirheumatic drugs (DMARDs), biologic, or prednisone for any duration for treatment of poly-JIA, with the following exceptions:
• Methotrexate duration must be less than or equal to 6 weeks at a dose of less than or equal to 0.5 mg/kg/week (40 mg max),
• Steroid use has been less than or equal to 4 weeks and the subject is off of steroids for at least 1 week prior to enrollment
• Received intramuscular or soft-tissue injections of corticosteroids for treatment of poly-JIA before receiving the first dose of study medication. Up to 2 joint injections with intra-articular steroids (IAS) will be allowed up to 7 days after the baseline visit.
• History of or active cancer of any type
• Active gastrointestinal disease (e.g., inflammatory bowel disease)
• Chronic or acute kidney or liver disorder
• Significant blood clotting defect
• AST (SGOT), ALT (SGPT), or BUN levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline
• Chronic condition (e.g., diabetes, epilepsy) that is either not stable or poorly controlled and may interfere with study participation
• Received any investigational medication within 30 days prior to the first dose of study medication or scheduled to receive an investigational drug (other than the study medications) during the course of the study
• Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to study screening
• HIV infected
• Known past or current hepatitis infection
• Received a live virus vaccine within 1 month prior to baseline
• Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
• Pregnancy
• Any medical condition that would make study participation difficult or inadvisable in the opinion of the investigator
• History of or current psychiatric illness that would interfere with study participation
• History of alcohol or drug abuse within the 6 months prior to study entry that would interfere with study participation
• Inability to comply with study requirements for any reason