Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

NCT ID: NCT01803321

Last Updated: 2013-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Systemic Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1

Dose 1

Group Type EXPERIMENTAL

rilonacept (IL-1 Trap)

Intervention Type DRUG

Placebo

Intervention Type OTHER

Cohort 2

Dose 2

Group Type EXPERIMENTAL

rilonacept (IL-1 Trap)

Intervention Type DRUG

Placebo

Intervention Type OTHER

Interventions

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rilonacept (IL-1 Trap)

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* Use of certain medications prior to the baseline visit
* History of recurrent infections
Minimum Eligible Age

4 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Los Angeles, California, United States

Site Status

Wilmington, Delaware, United States

Site Status

Chicago, Illinois, United States

Site Status

Hackensack, New Jersey, United States

Site Status

Long Island City, New York, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Cleveland, Ohio, United States

Site Status

Dallas, Texas, United States

Site Status

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23754188 (View on PubMed)

Other Identifiers

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IL1T-AI-0504

Identifier Type: -

Identifier Source: org_study_id

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