Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis
Condition: Juvenile Chronic Polyarthritis; Juvenile Idiopathic Arthritis; Juvenile Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare two aggressive drug regimens for children with
      poly-juvenile idiopathic arthritis (JIA) and extended oligo JIA.
    

Detailed description: 
      JIA is a type of arthritis with no definite cause and an onset prior to 16 years of age. JIA
      causes joint destruction, pain, and permanent disability. There are multiple types of JIA;
      collectively, they represent one of the most common chronic diseases in children and the most
      prevalent pediatric rheumatic illness. Poly-JIA, one type of JIA, affects at least five
      joints in the body within the first 6 months of disease. Long-term remission of poly-JIA is
      uncommon, and most children must remain on multiple combinations of medications for many
      years. The usual treatment for poly-JIA is based upon the gradual addition of medications
      that might be more effective in treating this disease. There is a need to find uniformly
      effective treatments for children with poly-JIA. Based on previous adult arthritis studies,
      there appears to be an early window of opportunity in the disease progression during which
      aggressive therapy has a profound beneficial long-term effect. The purpose of this study is
      to compare the effectiveness of two aggressive drug regimens in treating children with
      poly-JIA. Specifically, the study will determine whether aggressive therapy started in the
      first 6 months of disease onset can result in inactive disease and clinical remission while
      on these medications.

      All participants will receive weekly methotrexate shots while in the study. In addition,
      participants will be randomly assigned to one of two groups:

        -  Group 1 participants will receive placebo etanercept shots for up to 12 months and daily
           placebo prednisolone liquid for 4 months.

        -  Group 2 participants will receive etanercept shots for up to 12 months and daily
           prednisolone liquid for 4 months.

      The study will last up to 12 months and include two parts. Part A will last 1 to 6 months,
      depending on response to assigned treatments. If participants are still experiencing active
      arthritis at 6 months, they will be offered open-label treatment with etanercept and
      prednisolone. If participants experience inactive disease any time prior to 6 months, they
      will enter Part B of the study. During Part B, which will last up to 6 months, participants
      will remain on the same treatment regimen that they were provided in Part A. If participants
      experience inactive disease followed by a flare of disease any time during the study, they
      will stop participating.

      During the study, there will be 11 study visits for all participants. Study visits will
      include a physical exam, including joint evaluations; blood and urine collection; and
      questionnaires regarding function, quality of life, medication compliance, other medications
      used, infections, and adverse symptoms.

      Blood will be collected for translational studies.
    

Intervention name(s): methotrexate; methotrexate - etanercept - prednisolone arm
Intervention type(s): Drug; Drug
Intervention description(s): Methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus placebo etanercept and and placebo prednisolone; methotrexate 0.5 mg/kg given by sub cutaneous injection once per week, plus etanercept 0.8 mg/kg given by sub cutaneous injection once per week, plus prednisolone, by mouth daily with decreasing dose tapered over 16 weeks.
Other intervention name(s): placebo enbrel; placebo prednisolone; enbrel; prednisone
Intervention MeSH terms: Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Etanercept; Methotrexate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Childhood Arthritis; Juvenile Arthritis; Juvenile Arthritis Treatment; Childhood Arthritis Drug Treatment; Juvenile Arthritis Remission; Inactive Disease in Juvenile Arthritis; Childhood Polyarthritis; Extended Oligoarthritis