Overview
Study Evaluating the Efficacy and Safety of Etanercept
Status:
Completed
Completed
Trial end date:
2005-02-01
2005-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of PfizerTreatments:
Etanercept
Criteria
Inclusion Criteria:- A negative serum or urine pregnancy test at screening and a medically acceptable form
of contraception starting at screening and continuing throughout the study is required
for all females of childbearing potential (defined as an oral, injectable, or
implantable contraceptive, intrauterine device, or barrier method combined with a
spermicide).
- Failed therapy with at least one DMARD (DMARD failure is defined as a discontinuation
because of lack of clinical efficacy).
- Meet the 1987 American Rheumatism Association (ARA) revised criteria for rheumatoid
arthritis.
Exclusion Criteria:
- Uncooperative patients with a history of poor compliance.
- Known hypersensitivity to etanercept or any of its components.
- Known significant concurrent medical disease