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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 30, 2006 | ||||
| Last Updated Date | November 12, 2009 | ||||
| Start Date ICMJE | March 2006 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
PHYSICIAN GLOBAL ASSESSMENT [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00332332 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
QOL, Safety [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel in Psoriasis | ||||
| Official Title ICMJE | Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel in Psoriasis | ||||
| Brief Summary | The purpose of this study is to evaluate the use of Enbrel® (etanercept) in the treatment of psoriasis in patients for a period of up to 1 year. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Psoriasis | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | No Intervention: OPEN LABEL SINGLE ARM TREATMENT WITH ENBREL | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | September 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 18 years of age or older Moderate to severe plaque psoriasis Able to start Enbrel therapy per the approved product monograph Exclusion Criteria Active infections Evidence of skin conditions other than psoriasis that would interfere with study evaluations Subjects receiving Remicade (infliximab), Humira (adalimumab) or Amevive (alefacept) |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00332332 | ||||
| Responsible Party | Global Development Leader, Amgen Inc. | ||||
| Study ID Numbers ICMJE | 20050180 | ||||
| Study Sponsor ICMJE | Amgen | ||||
| Collaborators ICMJE | Wyeth | ||||
| Investigators ICMJE |
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| Information Provided By | Amgen | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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