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Treatment for Subjects with Active Rheumatoid Arthritis (RA) - Article


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Clinical Trial: Treatment for Subjects with Active Rheumatoid Arthritis (RA)

This study is no longer recruiting patients.

Sponsored by: Amgen
Information provided by: Amgen

Purpose

The purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with RA.

Condition Treatment or Intervention Phase
Rheumatoid Arthritis
 Drug: Etanercept Liquid
Phase III

MedlinePlus related topics:  Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Open Label, Safety/Efficacy Study

Official Title: Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects with Active Rheumatoid Arthritis (RA)

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Fulfill the 1987 American Rheumatism Association (ARA) criteria for RA
  • Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose of up to 25 mg a week is permitted
  • Screening lab results must demonstrate: *AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dL; *Platelet count greater than or equal to 125,000/cm3; *White blood cell count (WBC) greater than or equal to 3500 cells/cm3; *Serum creatinine less than or equal to 2 mg/dL
  • Before any study specific procedure is performed, the subject must provide informed consent for participation in the study

Exclusion Criteria:

  • Previous receipt of etanercept
  • Receipt of antibody to (tumor necrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1
  • Currently enrolled in other investigational device or drug trials, or participation in investigational trial within the past 30 days
  • Receipt of intra-articular corticosteroids within 14 days prior to Day 1
  • Receipt of any disease-modifying anti-rheumatic drugs (DMARDs) within 28 days of Day 1
  • Receipt of cyclophosphamide within 6 months of Day 1
  • Concomitant corticosteroids greater than 10 mg/day of prednisone (or equivalent) during 14 days prior to Day 1
  • Dose of nonsteroidal anti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must not exceed the recommended dose in the product information sheet
  • Subject is not using adequate contraception
  • Subject is pregnant or breast-feeding
  • Subject has significant concurrent medical disease

More Information

AmgenTrials clinical trials website

CenterWatch Clinical Trials Listing Service

Study ID Numbers:  20020378
Record last reviewed:  May 2005
Last Updated:  May 16, 2005
Record first received:  May 16, 2005
ClinicalTrials.gov Identifier:  NCT00110903
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17


Source: ClinicalTrials.gov
Cache Date: May 18, 2005

Resources



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Page Updated: June 1, 2005
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