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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00094341 |
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Date of registration:
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16/10/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
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Scientific title:
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An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes |
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Date of first enrolment:
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October 2004 |
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Target sample size:
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215 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00094341 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Amgen |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Etanercept
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Primary Outcome(s)
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The proportion of patients preferring the etanercept auto-injector to the etanercept pre-filled syringe.
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Secondary Outcome(s)
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Confidence with the injection
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Convenience of use and
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Satisfaction with number of steps
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Hand discomfort during the injection
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Ease of use
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Nervousness with injection
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Time involved with the injection
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Overall preference with the auto-injector or pre-filled syringes compared to the lyophilized preparation.
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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:
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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
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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