Treatment for Subjects With Active Rheumatoid Arthritis (RA)

Last updated: April 24, 2013
Sponsor: Amgen
Overall Status: Completed

Phase

3

Condition

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT00110903
20020378
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: - Fulfill the 1987 American Rheumatism Association (ARA) criteria forRA - Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose ofup 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 greaterthan 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 procedureis performed, the subject must provide informed consent for participation in the study

Exclusion

Exclusion Criteria: - Previous receipt of etanercept - Receipt of antibody to (tumornecrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1 - Currentlyenrolled in other investigational device or drug trials, or participation ininvestigational trial within the past 30 days - Receipt of intra-articularcorticosteroids within 14 days prior to Day 1 - Receipt of any disease-modifyinganti-rheumatic drugs (DMARDs) within 28 days of Day 1 - Receipt of cyclophosphamidewithin 6 months of Day 1 - Concomitant corticosteroids greater than 10 mg/day ofprednisone (or equivalent) during 14 days prior to Day 1 - Dose of nonsteroidalanti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must notexceed the recommended dose in the product information sheet - Subject is not usingadequate contraception - Subject is pregnant or breast-feeding - Subject hassignificant concurrent medical disease

Study Design

Study Start date:
Estimated Completion Date: