Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis - Full Text View

Sponsors and Collaborators:	Amgen Immunex Corporation
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00078806

Purpose

Rationale: etanercept inhibits the effects of tumor necrosis factor, which plays an important role in the progression of rheumatoid arthritis. A study of children with polyarticular course juvenile rheumatoid arthritis showed that Enbrel had efficacy and was generally well tolerated in children ages 4-17 who had moderately to severely active disease and who failed treatment with one or more disease modifying antiarthritic drugs. The children in the study may have had arthritis onset of pauciarticular, polyarticular, or systemic nature. Systemic onset juvenile rheumatoid arthritis (SOJRA) may result in approximately one-third of patients having significant long-term disability. Purpose: the Phase 4 study is designed to further define the safety and efficacy of etanercept in those children with SOJRA.

Condition	Intervention	Phase
Juvenile Rheumatoid Arthritis	Drug: Enbrel Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	Phase 3 Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Determine the efficacy of etanercept in pediatric subjects with systemically active systemic onset juvenile rheumatoid arthritis [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine population pharmacokinetics for children with systemically active SOJRA at 0.4 mg/kg etanercept twice weekly and at 0.8 mg/kg twice weekly [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Determine the effect on the cytokine profile in a substudy [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Determine the time to response during open-label treatment with etanercept [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Determine the safety of etanercept in pediatric subjects with systemically active SOJRA [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Determine the mean time to flare (up to 3 months) following withdrawal of etanercept in Part-2 [ Time Frame: 13 months ] [ Designated as safety issue: No ]
Determine the safety and benefit of higher doses of etanercept (up to 0.8 mg/kg twice weekly) in Part-1B for children who have had a partial response to etanercept at 0.4 mg/kg twice weekly in Part-1A [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	June 2001
Study Completion Date:	May 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Enbrel: Experimental	Drug: Enbrel Enbrel
Placebo: Placebo Comparator	Drug: Placebo placebo

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

2 - 18 years of age
SOJRA for at least 3 months, with stable systemic features
If taking methotrexate, hydroxychloroquine, or NSAIDs, dose must be stable
Must take prednisone at a stable dose EXCLUSION CRITERIA:
Need for other DMARDs or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids
Pregnant or nursing female
Clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology
Previous receipt of any TNF inhibitor
Live virus vaccine within 12 weeks of study entry
Participation in another study requiring informed consent within 12 weeks of entry
Diabetes that requires insulin treatment
Infection, chronic, recurrent, or currently active
Any serious medical or psychiatric condition or history of alcohol or drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078806

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

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

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20021631
Study First Received:	March 5, 2004
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00078806 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Systemic Onset Juvenile Rheumatoid Arthiritis
SOJRA
Fever
Rash
Joint Pain

Study placed in the following topic categories:

Anti-Inflammatory Agents
Arthritis, Juvenile Rheumatoid
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Pain
Rheumatic Diseases
TNFR-Fc fusion protein
Immunosuppressive Agents
Fever

Exanthema
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Arthralgia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Arthritis, Juvenile Rheumatoid
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Joint Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein
Immunosuppressive Agents

Pharmacologic Actions
Musculoskeletal Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009