An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Wyeth is now a wholly owned subsidiary of Pfizer0 sites300 target enrollmentJune 2004

ConditionsRheumatoid Arthritis

DrugsEtanercept Methotrexate

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 300
Primary Endpoint: 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.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2004

End Date

September 2005

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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.