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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

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ClinicalTrials.gov Identifier: NCT00346294
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : February 20, 2009
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Etanercept Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2006
Primary Completion Date : March 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Single-Arm
Open-lable Single Arm Study
Other: Etanercept
Intervention type was to study the drug delivery method.


Outcome Measures

Primary Outcome Measures :
  1. To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects. [ Time Frame: 22 Days ]

Secondary Outcome Measures :
  1. To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects. [ Time Frame: 22 Days ]
  2. To determine the rate of failed drug deliveries (as opposed to device failures). [ Time Frame: 22 Days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346294


Sponsors and Collaborators
Amgen
Immunex Corporation
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00346294     History of Changes
Other Study ID Numbers: 20050207
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by Amgen:
Rheumatoid Arthritis
Device
Auto-injector
SureClick
Enbrel
Etanercept

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors