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An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis

NCT ID: NCT00346294

Last Updated: 2020-01-22

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

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-07-31

Brief Summary

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An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.

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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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Single-Arm

Open-lable Single Arm Study

Group Type OTHER

Etanercept

Intervention Type DRUG

Intervention type was to study the drug delivery method.

Interventions

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Etanercept

Intervention type was to study the drug delivery method.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* RA subjects
* 18 years or older
* Currently taking etanercept in pre-filled syringes for at least 4 weeks
* Subjects must give written informed consent

Exclusion Criteria

* Subject is pregnant or breast feeding
* Significant concurrent medical diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunex Corporation

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Related Links

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http://www.enbrel.com/

FDA-approved Drug Labeling

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20050207

Identifier Type: -

Identifier Source: org_study_id

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