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Study Evaluating the Combinat...

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

Last Updated: 2011-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Etanercept

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers