Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis
NCT ID: NCT00322439
Last Updated: 2018-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
2511 participants
OBSERVATIONAL
2006-05-01
2013-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Etanercept
Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Etanercept
Observational study - no drug administered
Interventions
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Etanercept
Observational study - no drug administered
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients for whom Enbrel is contraindicated
* Patients currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Creamer K, McCroskery P, Kricorian G, Gelfand JM. OBSERVE-5, an Observational Post-Marketing SafetySurveillance Registry of Etanercept for the treatment of Psoriasis: A Model for Studying New Psoriasis Therapies. Psoriasis Forum. 2010;16(3):3-7.
Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Yong M, Creamer K, Hooper M, Aras G, Kricorian G, Gelfand JM. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol. 2013 May;68(5):756-64. doi: 10.1016/j.jaad.2012.10.055. Epub 2013 Jan 26.
Kimball AB, Rothman KJ, Kricorian G, Pariser D, Yamauchi PS, Menter A, Teller CF, Aras G, Accortt NA, Hooper M, Rice KC, Gelfand JM. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results. J Am Acad Dermatol. 2015 Jan;72(1):115-22. doi: 10.1016/j.jaad.2014.08.050. Epub 2014 Sep 26.
Kimball AB, Schenfeld J, Accortt NA, Anthony MS, Rothman KJ, Pariser D. Incidence rates of malignancies and hospitalized infectious events in patients with psoriasis with or without treatment and a general population in the U.S.A.: 2005-09. Br J Dermatol. 2014 Feb;170(2):366-73. doi: 10.1111/bjd.12744.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20040210
Identifier Type: -
Identifier Source: org_study_id
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