Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Rilonacept
Intervention description: 2.2 mg/kg subcutaneously
Intervention MeSH terms: Rilonacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 18 Months
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Systemic Juvenile Idiopathic Arthritis; Juvenile Rheumatoid Arthritis; Systemic Juvenile Rheumatoid Arthritis

Summary:

      Systemic juvenile idiopathic arthritis (SJIA) is a type of arthritis that typically occurs
      before 16 years of age. SJIA usually involves heat, pain, swelling, and stiffness in the
      body's joints. It can also involve fever, rash, anemia, and inflammation in various parts of
      the body. Rilonacept is a drug that can reduce inflammation. The purpose of this study is to
      determine whether a rilonacept drug regimen initiated early is more effective than a similar
      rilonacept drug regimen initiated 4 weeks later when treating children and young adults with
      SJIA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fulfills International League Against Rheumatism (ILAR) criteria for SJIA

          -  Duration of SJIA lasting at least 6 weeks since onset

          -  Active disease as defined by at least two joints with active disease

          -  Not currently receiving methotrexate OR if taking methotrexate, the dose has remained
             stable or has been discontinued for 4 weeks prior to screening

          -  Has never received certain biologics OR if previously received biologics, discontinued
             etanercept for at least 4 weeks prior to screening and discontinued infliximab or
             adalimumab for at least 8 weeks prior to screening

          -  Not currently receiving corticosteroids OR if taking oral corticosteroids, the dose
             has remained stable between 2 and 60 mg/day for at least 2 weeks prior to screening

        Exclusion Criteria:

          -  Past treatment with anakinra, rilonacept, or other biologic IL-1 inhibitor

          -  Treatment with other disease-modifying antirheumatic drugs (DMARDs) including, but not
             limited to, azathioprine, sulfasalazine, cyclosporine, and thalidomide within 4 weeks
             of screening

          -  Treatment with leflunomide without cholestyramine washout at the end of therapy

          -  Treatment with cyclophosphamide within 3 months of study entry

          -  Treatment with tacrolimus or tocilizumab within 4 weeks of study entry

          -  Treatment with rituximab within 6 months of study entry

          -  Treatment with intravenous immunoglobulin (IVIG) within 4 weeks of screening

          -  Kidney disease

          -  AST or ALT levels more than two times the upper limit of normal

          -  Bilirubin levels higher than 1.5 mg/dl

          -  Thrombocytopenia, leukopenia, or neutropenia

          -  Abnormal prothrombin time (PT) and partial thromboplastin time (PTT) tests

          -  Low levels of plasma fibrinogen

          -  Evidence of chronic recurrent infection or other significant, non-SJIA illness that
             might interfere with study participation

          -  Psychological or cognitive difficulties that might interfere with study participation

          -  Current drug or alcohol abuse

          -  Anticipated poor compliance to assigned study regimen

          -  Participation in another clinical trial within 30 days of study entry

          -  Major surgical procedure within 3 months of study entry