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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01803321 |
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Date of registration:
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28/02/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
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Scientific title:
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A Pilot, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA) |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01803321 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Clinical Trial Management |
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Address:
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Telephone:
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Email:
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Affiliation:
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Regeneron Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria include, but are not limited to, the following:
- Patients aged 4 to less than 21 years who meet the criteria for active SJIA
- Must have been on a stable dose of non-steroidal anti-inflammatory drugs (NSAIDs) for
at least 4 weeks prior to the screening visit
Exclusion Criteria include, but are not limited to, the following:
- Use of certain medications prior to the baseline visit
- History of recurrent infections
Age minimum:
4 Years
Age maximum:
20 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Juvenile Idiopathic Arthritis
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Intervention(s)
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Drug: rilonacept (IL-1 Trap)
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Other: Placebo
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Primary Outcome(s)
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Frequency of treatment emergent adverse events (TEAEs)
[Time Frame: Baseline to Week 123]
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Secondary ID(s)
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IL1T-AI-0504
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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