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

This study has been terminated.
(the study was terminated because of slow enrollment)
Sponsor:
Collaborator:
Immunex Corporation
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00078806
First received: March 5, 2004
Last updated: April 30, 2009
Last verified: April 2009
  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 3

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

Resource links provided by NLM:


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
Experimental: Enbrel Drug: Enbrel
Enbrel
Placebo Comparator: Placebo 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
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: NCT00078806

Sponsors and Collaborators
Amgen
Immunex Corporation
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00078806     History of Changes
Obsolete Identifiers: NCT00039949
Other Study ID Numbers: 20021631
Study First Received: March 5, 2004
Last Updated: April 30, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014