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

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

Completed

Looking for future studies?

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

Intervention type was to study the drug delivery method.

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

Immunex Corporation

Registry information

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Jun 29, 2006
Registry last updated: Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed