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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 October 2017 |
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Main ID: |
NCT00683384 |
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Date of registration:
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21/05/2008 |
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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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Study Evaluating the Safety of Enbrel (Etanercept)
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Scientific title:
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A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Etanercept (Enbrel) 25 mg by Subcutaneous Injection |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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93 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00683384 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Philippines
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients from the study center who received or will receive at least one dose of
Enbrel according to the approved product indication.
Exclusion Criteria:
- Previously discontinued Enbrel therapy due to significant safety concern.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arthritis, Psoriatic
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Intervention(s)
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Drug: Etanercept (Enbrel)
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Primary Outcome(s)
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Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection
[Time Frame: 30 days post injection up to 3 years]
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Secondary ID(s)
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0881A-102300
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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