Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis - Full Text View

Sponsors and Collaborators:	Amgen Immunex Corporation
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00078793

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®

MedlinePlus related topics: Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: Methotrexate Etanercept

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Sponsors and Collaborators

Amgen

Immunex Corporation

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20021626, 016.0026
Study First Received:	March 5, 2004
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00078793
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

JRA
Registry

Study placed in the following topic categories:

Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases
TNFR-Fc fusion protein

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009