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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01803321
First received: February 28, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Systemic Juvenile Idiopathic Arthritis
Drug: rilonacept (IL-1 Trap)
Other: Placebo
Phase 1

Study Type: Interventional
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
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Frequency of treatment emergent adverse events (TEAEs) [ Time Frame: Baseline to Week 123 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: November 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dose 1
Drug: rilonacept (IL-1 Trap) Other: Placebo
Experimental: Cohort 2
Dose 2
Drug: rilonacept (IL-1 Trap) Other: Placebo

  Eligibility

Ages Eligible for Study:   4 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803321

Locations
United States, California
Los Angeles, California, United States
United States, Delaware
Wilmington, Delaware, United States
United States, Illinois
Chicago, Illinois, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, New York
Long Island, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
United States, Texas
Dallas, Texas, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided by Regeneron Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01803321     History of Changes
Other Study ID Numbers: IL1T-AI-0504
Study First Received: February 28, 2013
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Regeneron Pharmaceuticals:
SJIA

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014