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

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Etanercept

• Registration Number: NCT00346294
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-03
• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-06-28
• Study First Posted: 2006-06-29
• Study Completion: 2006-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm	Etanercept	Open-lable Single Arm Study

Primary Outcome Measures

Name	Time	Method
To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.	22 Days

Secondary Outcome Measures

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