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This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose 1 |
|
| Cohort 2 | Experimental | Dose 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rilonacept (IL-1 Trap) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of treatment emergent adverse events (TEAEs) | Baseline to Week 123 |
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Inclusion Criteria include, but are not limited to, the following:
Exclusion Criteria include, but are not limited to, the following:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23754188 | Derived | Lovell DJ, Giannini EH, Reiff AO, Kimura Y, Li S, Hashkes PJ, Wallace CA, Onel KB, Foell D, Wu R, Biedermann S, Hamilton JD, Radin AR. Long-term safety and efficacy of rilonacept in patients with systemic juvenile idiopathic arthritis. Arthritis Rheum. 2013 Sep;65(9):2486-96. doi: 10.1002/art.38042. |
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|
| Wilmington |
| Delaware |
| United States |
| Chicago | Illinois | United States |
| Hackensack | New Jersey | United States |
| Long Island City | New York | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Dallas | Texas | United States |
| Seattle | Washington | United States |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C531377 | rilonacept |
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