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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The current standard treatment for SJIA includes nonsteroidal anti-inflammatory drugs
      (NSAIDS) and corticosteroids. However, in most people, NSAIDS do not completely control the
      disease. Also, no studies have been done to prove which medication or combination of
      medications is best to treat children and adolescents with SJIA. Interleukin-1 (IL-1), a
      protein secreted by certain cells in the body, assists in regulating immune and inflammatory
      responses. Too much IL-1 can be harmful and has been shown to play a role in the inflammation
      associated with a variety of diseases, including SJIA. Rilonacept is a drug that inhibits
      IL-1 activity. 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. This study will also evaluate the
      safety of rilonacept, and various tissue samples will be collected from participants for
      future genetic studies.

      This study will last 6 months. Participants will be randomly assigned to one of two groups:

        -  Group 1 participants will receive rilonacept injections at a dose of 4.4mg/kg at study
           entry (loading dose), then 2.2 mg/kg weekly until Week 4. At Week 4, they will receive a
           loading dose of placebo, followed by weekly rilonacept injections at 2.2 mg/kg for the
           duration of the study.

        -  Group 2 participants will receive placebo at study entry and then during the first 4
           weeks of treatment. At Week 4, they will receive a loading dose of rilonacept injections
           of 4.4 mg/kg, followed by weekly rilonacept injections at a dose of 2.2 mg/kg for the
           duration of the study.

      Participants will continue any previous corticosteroid therapy, but in tapering doses. All
      participants will attend study visits at Weeks 0, 2, 4, 6, 8, 10, 12, 14 and 24. Study visits
      will include a physical exam, joint exam, blood collection, interview, and questionnaires.
      Urine collection may occur for some female participants. Other evaluations may be performed
      by the participant's regular doctor. Throughout the study, participants will maintain at-home
      diaries to record fever, morning stiffness and pain, when rilonacept or placebo was taken,
      any side effects experienced from treatment, and any additional medications that were taken.
    

Intervention name(s): Rilonacept
Intervention type(s): Biological
Intervention description(s): 2.2 mg/kg subcutaneously
Other intervention name(s): IL-1 Trap; Arcalyst
Intervention MeSH terms: Rilonacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Systemic Juvenile Idiopathic Arthritis; Juvenile Rheumatoid Arthritis; Systemic Juvenile Rheumatoid Arthritis