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OpenTrials
Completed

NCT Number: NCT00094341

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

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®.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

Primary outcomes

  1. The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.

Secondary outcomes

  1. 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:

  2. Ease of use

  3. Hand discomfort during the injection

  4. Satisfaction with number of steps

  5. Time involved with the injection

  6. Nervousness with injection

  7. Confidence with the injection

  8. Convenience of use and

  9. Overall preference with the auto-injector or pre-filled syringes compared to the lyophilized preparation.

  10. 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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2004
First posted
Oct 18, 2004
Registry last updated
Dec 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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