Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis (ACUTE-JIA)
Juvenile Idiopathic Arthritis
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring juvenile idiopathic arthritis, polyarthritis, combination therapy, biologic agents, TNF antagonists, infliximab
Eligibility Criteria
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
Sites / Locations
- Rheumatism Foundation Hospital
- Hospital for Children and Adolescents
- Kuopio University Hospital
- Oulu University Central Hospital
- Tampere University Hospital
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Infliximab plus Methotrexate
Combination of DMARDs
Methotrexate alone
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 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.
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.