| Original Study ID : 0881A6-101764 |
| NCT ID : NCT00195507 |
| Brief Title : Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis |
| Official Title : A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis |
| Brief Summary : This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis. |
| Source : Wyeth |
| Overall Status : Completed |
| Start Date : December 2004 |
| End Date : February 2007 |
| Completion Date : February 2007 |
| Official Title : Phase 4 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Enrollment : 700 |
| Verification Date : May 2007 |
| First Received Date : September 13, 2005 |
| Trial Eligibility |
| Criteria : 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 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| City : Wien |
| Zip Code : 1090 |
| Country : Austria |
| City : Feldkirch |
| Zip Code : 1090 |
| Country : Austria |
| City : Wien |
| Zip Code : 1160 |
| Country : Austria |
| City : Liege |
| Zip Code : 4000 |
| Country : Belgium |
| City : Bruxelles |
| Zip Code : B-1200 |
| Country : Belgium |
| City : Bruxelles |
| Zip Code : B-1070 |
| Country : Belgium |
| City : Edegem |
| Zip Code : B-2650 |
| Country : Belgium |
| City : Gent |
| Zip Code : B-9000 |
| Country : Belgium |
| City : Leuven |
| Zip Code : B-3000 |
| Country : Belgium |
| City : Praha 8 |
| Zip Code : 180 01 |
| Country : Czech Republic |
| City : Aarhus C |
| Zip Code : 8000 |
| Country : Denmark |
| City : Roskilde |
| Zip Code : 4000 |
| Country : Denmark |
| City : Odense C |
| Zip Code : 5000 |
| Country : Denmark |
| City : Lahti |
| Zip Code : 151 70 |
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| City : Kuopio |
| Zip Code : 702 11 |
| Country : Finland |
| City : Lyon Cedex 03 |
| Zip Code : 69437 |
| Country : France |
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| Zip Code : E11 1NR |
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| Zip Code : NR4 7UY |
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| Zip Code : AB25 1LD |
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| Zip Code : LS1 3EX |
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| Zip Code : LA1 4RP |
| Country : United Kingdom |
| OutComes |
| Primary OutComes |
| Measure : Compare the efficacy of continuous versus intermittent etanercept treatment regimens over 54 weeks in subjects with psoriasis |
| Secondary OutComes |
| Measure : Compare the effectiveness of two etanercept (ETN) treatment regimens as measured by patient reported outcomes. |
| Measure : Compare the time course of initial treatment response of the two ETN treatment regimens. |
| Measure : Evaluate the safety and tolerability profile of the two ETN treatment regimens. |
| Interventions |
| Type : Drug |
| Name : Etanercept |
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