Overview
Etanercept SFP in RA Patients
Status:
Completed
Completed
Trial end date:
2007-10-01
2007-10-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AmgenCollaborator:
Wyeth is now a wholly owned subsidiary of PfizerTreatments:
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