Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT00534495
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
19 Years
Study:
NCT00534495
Study Brief:
Protocol Section:
NCT00534495