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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00078806
Recruitment Status : Terminated (the study was terminated because of slow enrollment)
First Posted : March 9, 2004
Last Update Posted : May 1, 2009
Immunex Corporation
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Juvenile Rheumatoid Arthritis Drug: Enbrel Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Study Start Date : June 2001
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Arm Intervention/treatment
Experimental: Enbrel Drug: Enbrel

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Determine the efficacy of etanercept in pediatric subjects with systemically active systemic onset juvenile rheumatoid arthritis [ Time Frame: 13 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. Determine the effect on the cytokine profile in a substudy [ Time Frame: 13 months ]
  3. Determine the time to response during open-label treatment with etanercept [ Time Frame: 13 months ]
  4. Determine the safety of etanercept in pediatric subjects with systemically active SOJRA [ Time Frame: 13 months ]
  5. Determine the mean time to flare (up to 3 months) following withdrawal of etanercept in Part-2 [ Time Frame: 13 months ]
  6. 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 ]

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00078806

Sponsors and Collaborators
Immunex Corporation
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00078806     History of Changes
Obsolete Identifiers: NCT00039949
Other Study ID Numbers: 20021631
First Posted: March 9, 2004    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009

Keywords provided by Amgen:
Systemic Onset Juvenile Rheumatoid Arthiritis
Joint Pain

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors