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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

Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Etanercept (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

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

Clinical Details

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 design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Starting date: January 2006
Ending date: March 2006
Last updated: December 20, 2007

Page last updated: June 20, 2008

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