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


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Rheumatoid Arthritis


Clinical Trial: Safety and Efficacy Study of Etanercept (Enbrel®) In Children with Systemic Onset Juvenile Rheumatoid Arthritis

This study is no longer recruiting patients.

Sponsored by: Amgen
Information provided by: Amgen

Purpose

This study will determine the efficacy of etanercept in children with systemically active systemic onset juvenile rheumatoid arthritis (SOJRA).

Condition Treatment or Intervention Phase
Arthritis, Juvenile Rheumatoid
 Drug: Enbrel®
Phase III

MedlinePlus related topics:  Juvenile Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Placebo Control, Safety/Efficacy Study

Official Title: Phase 3 Safety and Efficacy Study of Etanercept (Enbrel®) In Children with Systemic Onset Juvenile Rheumatoid Arthritis

Eligibility

Ages Eligible for Study:  2 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

  • Patients must have systemic features of SOJRA
  • Active joints
  • Abnormal labs; albumin, platelets, Hgb, CRP
  • Stable dose of Prednisone
  • Stable dose or Off Methotrexate for 4 weeks
  • Blinded, placebo controlled

Location Information


Idaho
      Research Center, Boise,  Idaho,  United States

Massachusetts
      Research Center, Boston,  Massachusetts,  United States

Canada, British Columbia
      Research Center, Vancouver,  British Columbia,  Canada

Canada, Nova Scotia
      Research Center, Halifax,  Nova Scotia,  Canada

Canada, Ontario
      Research Center, Toronto,  Ontario,  Canada

Canada, Quebec
      Research Center, Montreal,  Quebec,  Canada

More Information

AmgenTrials clinical trials website

Center Watch Clinical Trials Listing Service

Study ID Numbers:  20021631
Record last reviewed:  February 2005
Last Updated:  February 4, 2005
Record first received:  March 5, 2004
ClinicalTrials.gov Identifier:  NCT00078806
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: December 9, 2005
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