Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00078793
First received: March 5, 2004
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

This study will evaluate long-term safety of etanercept with or without other DMARDs in children with polyarticular course or systemic juvenile rheumatoid arthritis (JRA) compared to a cohort of subjects with polyarticular or systemic JRA receiving methotrexate with or without other DMARDs.


Condition Intervention
Juvenile Rheumatoid Arthritis
Drug: Enbrel®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Adverse event rates and severity [ Time Frame: 36 months of observation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Growth data and Tanner scores [ Time Frame: 36 months of observation ] [ Designated as safety issue: Yes ]

Enrollment: 600
Study Start Date: June 2000
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Methotrexate group
Includes subjects being treated with methotrexate alone or in combination with other DMARDs with the exception of etanercept.
Drug: Enbrel®
Etanercept alone, etanercept plus methotrexate or other DMARDs

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric subjects age 2 to < or = 18 years of age with polyarticular course or systemic JRA who have recently started and are currently receiving: etanercept alone or in combination with methotrexate or other DMARDs; methotrexate alone or in combination with other DMARDs.The population includes pediatric subjects who completed Immunex protocol 016.0028 and selected other Immunex protocols will be eligible for this study once they change to marketed etanercept.

Criteria
  • JRA by American College of Rheumatology (ACR) criteria - Active joints - Initiate etanercept alone, etanercept plus methotrexate or other DMARDs, methotrexate alone, or methotrexate with other DMARDs within 6 months of entry into Registry
  • Polyarticular or systemic RA in 3 or more joints at start of treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078793

Sponsors and Collaborators
Amgen
Immunex Corporation
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00078793     History of Changes
Obsolete Identifiers: NCT00016575
Other Study ID Numbers: 20021626, 016.0026
Study First Received: March 5, 2004
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
JRA
Registry

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
TNFR-Fc fusion protein
Immunoglobulin G
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal

ClinicalTrials.gov processed this record on July 31, 2014