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
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 April 16, 2014