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.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00346294
First received: June 27, 2006
Last updated: February 19, 2009
Last verified: February 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

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

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
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014