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NCT00346294 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00346294
Other study ID # 20050207
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2006
Est. completion date July 2006

Study information
Verified date January 2020
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 115
Est. completion date July 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Etanercept
Intervention type was to study the drug delivery method.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Amgen Immunex Corporation

Outcome
Type Measure Description Time frame Safety issue
Primary To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects. 22 Days
Secondary To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects. 22 Days
Secondary To determine the rate of failed drug deliveries (as opposed to device failures). 22 Days
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