Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Wyeth is now a wholly owned subsidiary of Pfizer300 enrolled

Overview

This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Rheumatoid Arthritis

Interventions

EtanerceptDRUG

MethotrexateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who completed the previous double-blind,randomized study. * Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so. Exclusion Criteria: * Dose of prednisone\>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation. * Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.

Outcomes

Primary Outcomes

To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.

Secondary Outcomes

To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.