Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis
Phase IV Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis
2 other identifiers
observational
600
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2000
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedFirst Submitted
Initial submission to the registry
March 5, 2004
CompletedFirst Posted
Study publicly available on registry
March 9, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedMay 14, 2013
May 1, 2013
7.6 years
March 5, 2004
May 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse event rates and severity
36 months of observation
Secondary Outcomes (1)
Growth data and Tanner scores
36 months of observation
Study Arms (1)
Methotrexate group
Includes subjects being treated with methotrexate alone or in combination with other DMARDs with the exception of etanercept.
Interventions
Eligibility Criteria
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.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Amgenlead
- Immunex Corporationcollaborator
Related Publications (2)
Giannini EH, Ilowite NT, Lovell DJ, Wallace CA, Rabinovich CE, Reiff A, Higgins G, Gottlieb B, Chon Y, Zhang N, Baumgartner SW. Effects of long-term etanercept treatment on growth in children with selected categories of juvenile idiopathic arthritis. Arthritis Rheum. 2010 Nov;62(11):3259-64. doi: 10.1002/art.27682.
PMID: 20669280RESULTGiannini EH, Ilowite NT, Lovell DJ, Wallace CA, Rabinovich CE, Reiff A, Higgins G, Gottlieb B, Singer NG, Chon Y, Lin SL, Baumgartner SW; Pediatric Rheumatology Collaborative Study Group. Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis. Arthritis Rheum. 2009 Sep;60(9):2794-804. doi: 10.1002/art.24777.
PMID: 19714630RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2004
First Posted
March 9, 2004
Study Start
June 1, 2000
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
May 14, 2013
Record last verified: 2013-05