Trial Search Results

Safety and Effectiveness of Rilonacept for Treating Systemic Juvenile Idiopathic Arthritis in Children and Young Adults

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Montefiore Medical Center

Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


  • Biological: Rilonacept


Phase 2


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

Ages Eligible for Study

18 Months - 19 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christy Sandborg
Not Recruiting