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

May 10, 2013 updated by: Amgen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse event rates and severity
Time Frame: 36 months of observation
36 months of observation

Secondary Outcome Measures

Outcome Measure
Time Frame
Growth data and Tanner scores
Time Frame: 36 months of observation
36 months of observation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

Immunex Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

March 5, 2004

First Submitted That Met QC Criteria

March 8, 2004

First Posted (Estimate)

March 9, 2004

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 10, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20021626
  • 016.0026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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