Study Evaluating the Efficacy and Safety of Etanercept

Wyeth

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546533

0881A-101101

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)