Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis
NCT00332332
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 18 years of age or older at baseline
- Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or severe on the Physician Global Assessment (score of 3, 4 or 5)
- Able to start Enbrel (Etanercept) therapy per the approved product monograph
- Active infections at the initiation of Enbrel therapy.
- Evidence of skin conditions (i.e. eczema) other than psoriasis that would interfere
with evaluations of the effect of study medication on psoriasis.
- Psoralen plus ultraviolet A radiation (PUVA) within 4 weeks or ultraviolet light B
(UVB) therapy within 2 weeks of study drug initiation.
- Oral retinoids, cyclosporine, methotrexate, or any other systemic anti-psoriasis
therapy within 4 weeks or efalizumab (Raptiva®) within 8 weeks of study drug
initiation and during the study period.
- Topical Vitamin A or D analog preparations, or anthralin within 2 weeks of study drug
initiation and during the study period.
- Have received Remicade® (infliximab), Humira® (adalimumab) or Amevive®(alefacept)
within 3 months before the initiation of study medication or during the study period.
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Descriptive Information | ||||
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Brief Title ICMJE | Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis | |||
Official Title ICMJE | Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis | |||
Brief Summary | The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of psoriasis in patients for a period of up to 1 year. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Psoriasis | |||
Intervention ICMJE | Biological: etanercept
etanercept subcutaneous injection Other Name: ENBREL | |||
Study Arms ICMJE | Experimental: etanercept
Open label etanercept 50 mg twice weekly subcutaneously (SC) for 3 months followed by 50 mg twice a week week SC for 9 months, for a total treatment period of 12 months. Intervention: Biological: etanercept | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 246 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | February 2010 | |||
Actual Primary Completion Date | July 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | Canada | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00332332 | |||
Other Study ID Numbers ICMJE | 20050180 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Amgen | |||
Study Sponsor ICMJE | Amgen | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |