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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00346294

Collaborator

Immunex Corporation (Industry)

115

Enrollment

Arm

5.9

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Etanercept	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Other: Single-Arm Open-lable Single Arm Study	Drug: Etanercept Intervention type was to study the drug delivery method.

Arm

Intervention/Treatment

Other: Single-Arm

Open-lable Single Arm Study

Drug: Etanercept

Intervention type was to study the drug delivery method.

Outcome Measures

Primary Outcome Measures

To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects. [22 Days]

Secondary Outcome Measures

To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects. [22 Days]
To determine the rate of failed drug deliveries (as opposed to device failures). [22 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: - Diagnosis of rheumatoid arthritis

RA subjects
18 years or older
Currently taking etanercept in pre-filled syringes for at least 4 weeks
Subjects must give written informed consent
Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception
Subject is pregnant or breast feeding
Significant concurrent medical diseases