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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00078793

Collaborator

Immunex Corporation (Industry)

600

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Juvenile Rheumatoid Arthritis	Drug: Enbrel®

Study Design

Study Type:

Observational

Actual Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2000

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Adverse event rates and severity [36 months of observation]

Secondary Outcome Measures

Growth data and Tanner scores [36 months of observation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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