Juvenile Idiopathic Arthritis Clinical Trial
Official title:
Comparison of Anti-TNF Therapy Plus Methotrexate, Combination Therapy of DMARDs, and Methotrexate Alone in Very Early Polyarticular Juvenile Idiopathic Arthritis. A National Randomized Multicenter Clinical Trial.
The objective of this study is to compare in very early polyarticular juvenile idiopathic arthritis (JIA) the efficacy, safety, and cost-benefit-ratio of three treatment strategies: biologic combination, combination of conventional disease-modifying drugs (DMARDs), and methotrexate alone.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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