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
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