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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 : M10-114
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
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State : California
Zip Code : 90045
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State : Colorado
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State : Tennessee
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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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