Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis

DMARD-naive polyarticular JIA patients with an early disease (onset less than 6 months) are randomized into one of three treatment strategies: (1) biological combination, i.e., anti-TNF therapy with infliximab plus methotrexate; (2) Combination of DMARDs with methotrexate, sulfasalazine, plus hydroxychloroquine; and (3) Methotrexate alone.

The efficacy is evaluated by American College of Rheumatology Pediatric (ACR Pedi) criteria based on 6 core set variables (CSVs): 1. no of active joints; 2. no. of joints with pain or tenderness and limitation of motion; 3. ESR (mm/hr); 4. the Childhood Health Assessment Questionnaire (CHAQ); 5. Physician's Visual Analogue Scale (VAS); 6. Patient/Parent VAS. To fulfill ACR Pedi 75 criteria, 3/6 CSVs have to improve 75% and not more than 1/6 CSV worsen more than 30%. All direct and indirect costs are documented.

The first phase of the study is open-label clinical trial lasting for 54 weeks. In the second phase of the study the patients are followed up to 5 years, and the long-term outcome of early aggressive therapy is analyzed. Serum, urine, and saliva samples are collected at 3 and 5 years for translational research.

Inclusion criteria

• juvenile idiopathic arthritis
• arthritis lasting for at least 6 weeks but not more than 6 months
• polyarticular disease with at least 5 active joints with at least 3 joints with pain or tenderness and limitation of motion
• no previous treatment with DMARDs

Exclusion criteria

• systemic JIA
• any abnormality in the hematopoietic or lymphatic system
• any major concurrent medical condition
• inadequate psychosocial situation
• pregnancy
• a non-abstinent female with reproductive capacity without regular contraceptive use