Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Infliximab plus methotrexate; Combination of DMARDs; Methotrexate alone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IFX given 3-5mg/kg every 6 weeks, oral MTX given 15mg/m2 weekly. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.; IFX given 3-5mg/kg every 6 weeks, oral MTX given 15mg/m2 weekly, SSZ 40mg/kg up to 2000mg daily, HCQ 5mg/kg daily. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.; Oral MTX given 15mg/m2 weekly. If ACR Pedi 75 is not reached by week 12, MTX dose is doubled up to parenteral 30 mg/m2 weekly dose. If patient does not reach ACR Pedi 30 after dose escalation, failure.
Other intervention name(s): IFX: Remicade, MTX: Trexan or Methotrexate; MTX: Trexan or Methotrexate, SSZ: Salazopyrin, HCQ: Oxiklorin; MTX: Trexan or Methotrexate
Intervention MeSH terms: Sulfasalazine; Infliximab; Methotrexate; Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: juvenile idiopathic arthritis; polyarthritis; combination therapy; biologic agents; TNF antagonists; infliximab