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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01803321
Other study ID # IL1T-AI-0504
Secondary ID
Status Completed
Phase Phase 1
First received February 28, 2013
Last updated February 28, 2013
Start date November 2005
Est. completion date June 2008

Study information

Verified date February 2013
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 20 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
rilonacept (IL-1 Trap)

Other:
Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of treatment emergent adverse events (TEAEs) Baseline to Week 123 Yes
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