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

Completed · Phase 2

Conditions studied: Juvenile Idiopathic Arthritis

In brief

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.

Key facts

Study ID

NCT00534495

Run by

Montefiore Medical Center

People needed

71

Starts

2008-11-01

Expected to finish

2013-06-01

Last updated by the study team

2015-12-11

Who can join

Age: 2 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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