Etanercept SFP in RA Patients

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA

• Naïve to etanercept therapy

• Able to self-inject investigational product or have a designee who can do so

• Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria

• Receipt of Corticosteroids> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product

• Receipt of MTX witin 30 days of 1st dose of investigational product

• Receipt of an other investigational drug within 30 days of 1st dose

• Receipt of TNF inhibitor therapy within 90 days of 1st dose

• Receipt of cyclophosphamide within 6 mo of 1st dose

• Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum recommended dose in the product info sheet

• Current use of insulin

• gnificant concurrent medical condition