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

Juvenile Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078793
• Other study ID #: 20021626
• Secondary ID: 016.0026
• Status: Completed
• Phase: N/A
• First received: March 5, 2004
• Last updated: May 10, 2013
• Start date: June 2000
• Est. completion date: January 2008

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT00016575

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Juvenile Rheumatoid Arthritis

Intervention

Drug:
• Enbrel®
Etanercept alone, etanercept plus methotrexate or other DMARDs

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Immunex Corporation

References & 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. Arth — View Citation

Giannini 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 s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event rates and severity		36 months of observation	Yes
Secondary	Growth data and Tanner scores		36 months of observation	Yes

External Links

•   AmgenTrials clinical trials website