Study Evaluating the Efficacy and Safety of Etanercept

Wyeth is now a wholly owned subsidiary of Pfizer40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

EtanerceptDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To assess the clinical efficacy of etanercept 25 mg administered twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.

Data from ClinicalTrials.gov

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