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

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®


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

Resource links provided by NLM:

Genetics Home Reference related topics: juvenile idiopathic arthritis rheumatoid arthritis

MedlinePlus related topics: Arthritis Juvenile Arthritis Rheumatoid Arthritis

Drug Information available for: Methotrexate Etanercept

U.S. FDA Resources

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 ]


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 (Child, Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Amgen

Immunex Corporation

Investigators


Study Director:	MD	Amgen

More Information

Additional Information:

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

Publications:

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.

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 selected categories of juvenile idiopathic arthritis. Arthritis Rheum. 2009 Sep;60(9):2794-804. doi: 10.1002/art.24777.


Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT00078793 History of Changes
Obsolete Identifiers:	NCT00016575
Other Study ID Numbers:	20021626 016.0026
Study First Received:	March 5, 2004
Last Updated:	May 10, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:


JRA Registry

Additional relevant MeSH terms:


Arthritis Arthritis, Rheumatoid Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Etanercept Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents

ClinicalTrials.gov processed this record on September 23, 2016