Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis
- Conditions
- Juvenile Idiopathic Arthritis
- Interventions
- Registration Number
- NCT01015547
- Lead Sponsor
- Helsinki University Central Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infliximab plus Methotrexate Infliximab plus methotrexate infliximab 3-5 mg/kg every 6 weeks, plus methotrexate 15 mg/m2 weekly given orally (dose escalation if ACR Pedi less than 75). no oral prednisolone. intra-articular steroids allowed. Methotrexate alone Methotrexate alone Conventional drug therapy: methotrexate 15mg/m2 weekly given orally (dose escalation and parenteral injection if ACR Pedi less than 75). no oral prednisolone. intra-articular steroids allowed. Combination of DMARDs Combination of DMARDs methotrexate 15mg/m2 weekly given orally (dose escalation and parenteral injection if ACR Pedi less than 75), plus standard doses of sulfasalazine and hydroxychloroquine. no oral prednisolone. intra-articular steroids allowed.
- Primary Outcome Measures
Name Time Method ACR Pedi 75 response 54 weeks from baseline (0)
- Secondary Outcome Measures
Name Time Method time spent in inactive disease 0 to 54 weeks cost-benefit ratio in each treatment arm 0 to 54 weeks drug survival 54 weeks occurrence of side-effects and adverse events 0 to 54 weeks clinically inactive disease at 54 weeks time spent in ACR Pedi 75 0 to 54 weeks Other ACR Pedi responses (30, 50, 70, 90, 100) 0 to 54 weeks
Trial Locations
- Locations (6)
Rheumatism Foundation Hospital
🇫🇮Heinola, Finland
Hospital for Children and Adolescents
🇫🇮Helsinki, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Kuopio University Hospital
🇫🇮Kuopio, Finland
Oulu University Central Hospital
🇫🇮Oulu, Finland
Turku University Hospital
🇫🇮Turku, Finland