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

This study has been completed.

First Received: June 27, 2006 Last Updated: February 19, 2009 History of Changes

Sponsors and Collaborators:	Amgen Immunex Corporation
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00346294

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Other: Etanercept	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-Injector in Subjects With Rheumatoid Arthritis

Further study details as provided by Amgen:

Primary Outcome Measures:

To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects. [ Time Frame: 22 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects. [ Time Frame: 22 Days ] [ Designated as safety issue: No ]
To determine the rate of failed drug deliveries (as opposed to device failures). [ Time Frame: 22 Days ] [ Designated as safety issue: No ]

Enrollment:	115
Study Start Date:	January 2006
Study Completion Date:	July 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single-Arm Open-lable Single Arm Study	Other: Etanercept Intervention type was to study the drug delivery method.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346294

Sponsors and Collaborators

Amgen

Immunex Corporation

Investigators

Study Director:

Amgen

More Information

Additional Information:

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050207
Study First Received:	June 27, 2006
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00346294 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Rheumatoid Arthritis
Device
Auto-injector

SureClick
Enbrel
Etanercept

Study placed in the following topic categories:

Anti-Inflammatory Agents
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein
Immunosuppressive Agents

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Joint Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009