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Clinical Trial Name - Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Mode
| Original Study ID : M10-315 |
| NCT ID : NCT00710580 |
| 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 : July 2008 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 350 |
| Verification Date : May 2009 |
| First Received Date : July 2, 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 : Birmingham |
| State : Alabama |
| Zip Code : 35233 |
| Country : United States |
| City : Birmingham |
| State : Alabama |
| Zip Code : 35205 |
| Country : United States |
| City : Scottsdale |
| State : Arizona |
| Zip Code : 85251 |
| Country : United States |
| City : Little Rock |
| State : Arkansas |
| Zip Code : 72205 |
| Country : United States |
| City : Bakersfield |
| State : California |
| Zip Code : 93309 |
| Country : United States |
| City : Vallejo |
| State : California |
| Zip Code : 94589 |
| Country : United States |
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| Country : United States |
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| Country : United States |
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| Country : United States |
| City : Newnan |
| State : Georgia |
| Zip Code : 30263 |
| Country : United States |
| City : Atlanta |
| State : Georgia |
| Zip Code : 30327 |
| Country : United States |
| City : Snellville |
| State : Georgia |
| Zip Code : 30078 |
| Country : United States |
| City : Alpharetta |
| State : Georgia |
| Zip Code : 30022 |
| Country : United States |
| City : Maywood |
| State : Illinois |
| Zip Code : 60153 |
| Country : United States |
| City : Plainfield |
| State : Indiana |
| Zip Code : 46168 |
| Country : United States |
| City : Louisville |
| State : Kentucky |
| Zip Code : 40202 |
| Country : United States |
| City : Owensboro |
| State : Kentucky |
| Zip Code : 42301 |
| Country : United States |
| City : Port Huron |
| State : Michigan |
| Zip Code : 48060 |
| Country : United States |
| City : Grand Blanc |
| State : Michigan |
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| Zip Code : 55432 |
| Country : United States |
| City : St. Louis |
| State : Missouri |
| Zip Code : 63110 |
| Country : United States |
| City : Omaha |
| State : Nebraska |
| Zip Code : 68131 |
| Country : United States |
| City : Omaha |
| State : Nebraska |
| Zip Code : 68144 |
| Country : United States |
| City : Berlin |
| State : New Jersey |
| Zip Code : 08009 |
| Country : United States |
| City : New York |
| State : New York |
| Zip Code : 10016 |
| Country : United States |
| City : Rochester |
| State : New York |
| Zip Code : 14623 |
| Country : United States |
| City : Wilmington |
| State : North Carolina |
| Zip Code : 28401 |
| Country : United States |
| City : Hickory |
| State : North Carolina |
| Zip Code : 28601 |
| Country : United States |
| City : Dayton |
| State : Ohio |
| Zip Code : 45408-1445 |
| Country : United States |
| City : Knoxville |
| State : Tennessee |
| Zip Code : 37934 |
| Country : United States |
| City : Dallas |
| State : Texas |
| Zip Code : 75230 |
| Country : United States |
| City : San Antonio |
| State : Texas |
| Zip Code : 78229 |
| Country : United States |
| City : Houston |
| State : Texas |
| Zip Code : 77058 |
| Country : United States |
| City : Seattle |
| State : Washington |
| Zip Code : 98101 |
| Country : United States |
| City : Milwaukee |
| State : Wisconsin |
| Zip Code : 53209 |
| 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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