Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)
Condition: Arthritis, Juvenile Idiopathic
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate
      adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis
      (JIA) who are either methotrexate (MTX) treated or non-MTX treated.
    

Detailed description: 
      The study design for this clinical trial was chosen to evaluate adalimumab in subjects who
      were either methotrexate (MTX)-naive or had been withdrawn from MTX at least 2 weeks prior to
      study drug administration (non-MTX stratum) or were inadequate responders to MTX and
      continued MTX treatment (MTX stratum). The study consisted of 4 phases: a 16-week Open-label
      Lead-in (OL LI), a 32-week Double-blind (DB) phase, an up to 136-week Open-label Extension
      Body Surface Area (OLE BSA) phase, and an up to 224-week OLE Fixed Dose (FD) phase. All
      subjects who met entry criteria were enrolled into one of the appropriate strata and received
      adalimumab (plus concomitant MTX in the MTX stratum) in the 16 week OL LI phase of the study.
      All subjects who responded to adalimumab during the OL LI phase were to be enrolled in the DB
      phase of the study and randomized to receive adalimumab (plus concomitant MTX in the MTX
      stratum) or placebo (plus concomitant MTX in the MTX stratum). Subjects in the DB phase
      received either adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose) or placebo
      subcutaneously (SC) administered every other week (eow). Adalimumab or placebo was
      administered for an additional 32 weeks or until flare of disease (based on PedACR30 response
      criteria = a worsening of 30% or more in 3 of the 6 response variables (Parent's global
      assessment of subject's overall well-being by visual analog scale [VAS], Physician's global
      assessment [PhGA] of subject's disease severity by VAS, number of active joints [joints with
      swelling not due to deformity or joints with limitation of passive motion (LOM)], pain,
      tenderness, or both, number of joints with LOM, Childhood Health Assessment Questionnaire
      [CHAQ], and CRP levels), a minimum of 2 active joints, and no more than 1 indicator improving
      by 30% or more), whichever occurred earlier. For subjects who did not have a disease flare,
      the DB phase was completed at Week 48. Subjects who experienced disease flare during the DB
      phase or subjects who completed 48 weeks of the study were given the option to receive
      adalimumab for up to a minimum of 44 weeks (up to a maximum of 136 weeks) in the OLE BSA
      phase before being eligible to switch to the OLE FD phase. In this phase, subjects received
      OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose SC eow). All subjects
      who completed at least 44 weeks of OLE BSA treatment were given the opportunity to continue
      into the OLE FD phase for up to 224 weeks of additional adalimumab exposure. In this phase,
      subjects weighing less than 30 kg were treated with a fixed dose of 20 mg of adalimumab SC
      eow. Subjects weighing 30 kg or more were treated with a fixed dose of 40 mg of adalimumab SC
      eow.
    

Intervention name(s): Double-Blind Adalimumab/Placebo + MTX; Double-Blind Adalimumab/Placebo; OLE BSA Adalimumab +/- MTX; OLE FD Adalimumab +/- MTX
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) concomitantly with MTX treatment for 32 weeks during the Double-Blind phase. Total body dose of adalimumab was not to exceed 40 mg.; Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) without MTX treatment for 32 weeks during the Double-Blind Phase. Total body dose of adalimumab was not to exceed 40 mg.; Comparison of subcutaneous injection of 24 mg adalimumab per square meter of body surface area (BSA) every other week (eow) either with or without concomitant MTX treatment for a minimum of 44 weeks (up to a maximum of 136 weeks) during the Open-Label Extension BSA Phase.; Comparison of adalimumab administered subcutaneously every other week (eow) either with or without concomitant MTX treatment for up to 224 weeks during the Open-Label Extension Fixed Dose (FD) Phase.
Other intervention name(s): ABT-D2E7; Humira; ABT-D2E7; Humira; ABT-D2E7; Humira; ABT-D2E7; Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polyarticular Juvenile Idiopathic Arthritis