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

Phase 4CompletedNCT00346294

Amgen115 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Rheumatoid Arthritis

Interventions

EtanerceptDRUG

Intervention type was to study the drug delivery method.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 22 Days

Secondary Outcomes

To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.

Time frame: 22 Days

To determine the rate of failed drug deliveries (as opposed to device failures).

Time frame: 22 Days

Data from ClinicalTrials.gov

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