Etanercept SFP in RA Patients

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

PHASE3

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-10-31

Brief Summary

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Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.

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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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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50 mg

50 mg once weekly

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

50 mg once weekly

Interventions

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Etanercept

50 mg once weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA
* Naïve to etanercept therapy
* Able to self-inject investigational product or have a designee who can do so

Exclusion Criteria

* Receipt of Corticosteroids\> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product
* Receipt of MTX witin 30 days of 1st dose of investigational product
* Receipt of an other investigational drug within 30 days of 1st dose
* Receipt of TNF inhibitor therapy within 90 days of 1st dose
* Receipt of cyclophosphamide within 6 mo of 1st dose
* Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum recommended dose in the product info sheet
* Current use of insulin
* gnificant concurrent medical condition

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No