| Original Study ID : M10-114 |
| NCT ID : NCT00691964 |
| Brief Title : Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
| Official Title : A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
| Brief Summary : Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis |
| Source : Abbott |
| Overall Status : Completed |
| Start Date : June 2008 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 347 |
| Verification Date : April 2009 |
| First Received Date : June 4, 2008 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: - Diagnosis of Psoriasis for 6 mo. - BSA 10%, PASI 12 or above, PGA 3 or above Exclusion Criteria: - Previous exposure to either etanercept or ABT-874 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| City : Fresno |
| State : California |
| Zip Code : 93720 |
| Country : United States |
| City : Los Angeles |
| State : California |
| Zip Code : 90045 |
| Country : United States |
| City : Denver |
| State : Colorado |
| Zip Code : 80209 |
| Country : United States |
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| State : Florida |
| Zip Code : 33136-1003 |
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| Zip Code : 30022 |
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| City : Arlington Heights |
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| Zip Code : 60005 |
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| City : West Dundee |
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| Zip Code : 60118 |
| Country : United States |
| City : Skokie |
| State : Illinois |
| Zip Code : 60077 |
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| City : Schaumburg |
| State : Illinois |
| Zip Code : 60194 |
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| State : Indiana |
| Zip Code : 46256 |
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| State : Massachusetts |
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| Zip Code : 87106 |
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| City : New York |
| State : New York |
| Zip Code : 10029-6501 |
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| City : Cleveland |
| State : Ohio |
| Zip Code : 44106 |
| Country : United States |
| City : Cincinnati |
| State : Ohio |
| Zip Code : 45219 |
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| City : Oklahoma City |
| State : Oklahoma |
| Zip Code : 73104 |
| Country : United States |
| City : Lake Oswego |
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| Zip Code : 97035 |
| Country : United States |
| City : Portland |
| State : Oregon |
| Zip Code : 97223 |
| Country : United States |
| City : Portland |
| State : Oregon |
| Zip Code : 97210 |
| Country : United States |
| City : Hershey |
| State : Pennsylvania |
| Zip Code : 17033 |
| Country : United States |
| City : Philadelphia |
| State : Pennsylvania |
| Zip Code : 19103 |
| Country : United States |
| City : Providence |
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| Zip Code : 02903 |
| Country : United States |
| City : Johnston |
| State : Rhode Island |
| Zip Code : 02919 |
| Country : United States |
| City : Greer |
| State : South Carolina |
| Zip Code : 29651 |
| Country : United States |
| City : Goodlettsville |
| State : Tennessee |
| Zip Code : 37072 |
| Country : United States |
| City : Tyler |
| State : Texas |
| Zip Code : 75703 |
| Country : United States |
| City : Dallas |
| State : Texas |
| Zip Code : 75246 |
| Country : United States |
| City : San Antonio |
| State : Texas |
| Zip Code : 78229 |
| Country : United States |
| City : Houston |
| State : Texas |
| Zip Code : 77030 |
| Country : United States |
| City : Austin |
| State : Texas |
| Zip Code : 78759 |
| Country : United States |
| City : Norfolk |
| State : Virginia |
| Zip Code : 23507 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Secondary OutComes |
| Measure : Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12 |
| Time Frame : 12 Weeks |
| Safety issue : No |
| Interventions |
| Type : Biological |
| Name : ABT-874 |
| Description : SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8 |
| Type : Biological |
| Name : etanercept |
| Description : SQ injection 50 mg BIW |
| Type : Drug |
| Name : placebo |
| Description : SQ placebo injections for ABT-874 and etanercept |
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