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

Wyeth

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: Methotrexate

Drug: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00252668

0881A1-101631

0881A1-400

B1801221

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.