Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00094341
First received: October 16, 2004
Last updated: December 4, 2008
Last verified: December 2008
  Purpose

The purpose of this study is to determine the preference of RA patients for the new Enbrel® (etanercept) pre-filled syringe in patients who are already taking Enbrel®.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Etanercept
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.

Secondary Outcome Measures:
  • The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe as well as to the lyophilized preparation in the following categories:
  • Ease of use
  • Hand discomfort during the injection
  • Satisfaction with number of steps
  • Time involved with the injection
  • Nervousness with injection
  • Confidence with the injection
  • Convenience of use and
  • Overall preference with the auto-injector or pre-filled syringes compared to the lyophilized preparation.
  • To characterize the ability of patients to properly use by themselves either device independently and identify any sections of the instructions that were not clear, that may have led to loss of sterility to incomplete dosing

Estimated Enrollment: 215
Study Start Date: October 2004
  Eligibility

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

Inclusion Criteria:

  • Have established RA diagnosis as determined by ACR criteria
  • Be current user of etanercept-lyophilized preparation for at least 4 consecutive weeks of etanercept dosing on either a once weekly or twice weekly regimen
  • Subject must be able to self inject
  • Give written informed consent

Exclusion Criteria:

  • Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
  • Subject of childbearing potential is pregnant (e.g., positive HCG test) or is breast-feeding
  • Elective surgery is planned during study period
  • Subjects allergic to latex
  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: NCT00094341

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

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00094341     History of Changes
Other Study ID Numbers: 20040201
Study First Received: October 16, 2004
Last Updated: December 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Arthritis
Rheumatology

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 September 18, 2014