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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: |
NCT00195507 |
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Date of registration:
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13/09/2005 |
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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 Etanercept in the Treatment of Subjects With Psoriasis
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Scientific title:
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A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis |
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Date of first enrolment:
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December 2004 |
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Target sample size:
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720 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00195507 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Austria
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Belgium
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Greece
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Hungary
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Italy
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Netherlands
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Norway
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Poland
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Portugal
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Spain
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Sweden
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Switzerland
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Turkey
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United Kingdom
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Hungary, WPBUMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, MedinfoDEU@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For UK, ukmedonfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Denmark, Finland, Sweden, Norway, MedInfoNord@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Italy,Greece, decresg@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Austria, WPVIMED@wyeth.com |
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Name:
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TRial manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Belgium, trials-BEL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Poland, WPWZMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Netherlands, trials-NL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Turkey, Erisc@wyeth.com |
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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:
- Stable, active plaque psoriasis
- Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine,
PUVA or Fumarate
Exclusion Criteria:
- Evidence of skin conditions other than psoriasis that would interfere with evaluations
of the effect of the study
- Systemic psoriasis therapy within 28 days prior
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Psoriasis
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Intervention(s)
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Drug: Etanercept
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Primary Outcome(s)
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Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks
[Time Frame: 54 weeks]
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Secondary Outcome(s)
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Number of Patients With Survey Response of "Somewhat Satisfied" or Better
[Time Frame: 54 weeks]
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Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline
[Time Frame: 54 weeks]
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Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"
[Time Frame: 54 weeks]
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Secondary ID(s)
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0881A6-101764
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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