Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 3

Completed

• Conditions: Moderate to Severe Plaque Psoriasis
• Interventions: Biological: ABT-874; Biological: etanercept; Drug: placebo

• Registration Number: NCT00710580
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Disposition First Submitted: 2011-08-23
• Disposition First Submitted QC: 2011-08-23
• Disposition First Posted: 2011-08-25
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	ABT-874	-
B	etanercept	-
C	placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12	12 Weeks
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12	12 Weeks

Trial Locations

Locations (42)

Site Reference ID/Investigator# 9981; 🇺🇸 Dallas, Texas, United States

Site Reference ID/Investigator# 10502; 🇺🇸 Little Rock, Arkansas, United States

Site Reference ID/Investigator# 10762; 🇺🇸 Atlanta, Georgia, United States

Site Reference ID/Investigator# 10662; 🇺🇸 Santa Monica, California, United States

Site Reference ID/Investigator# 10641; 🇺🇸 St. Louis, Missouri, United States

Site Reference ID/Investigator# 15142; 🇺🇸 Plainfield, Indiana, United States

Site Reference ID/Investigator# 9788; 🇺🇸 Fort Gratiot, Michigan, United States

Site Reference ID/Investigator# 14701; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator# 10661; 🇺🇸 Irvine, California, United States

Site Reference ID/Investigator# 10501; 🇺🇸 West Palm Beach, Florida, United States

Site Reference ID/Investigator# 10666; 🇺🇸 Maywood, Illinois, United States

Site Reference ID/Investigator# 10241; 🇺🇸 New York, New York, United States

Site Reference ID/Investigator# 10001; 🇺🇸 Scottsdale, Arizona, United States

Site Reference ID/Investigator# 10504; 🇺🇸 Dayton, Ohio, United States

Site Reference ID/Investigator# 10604; 🇺🇸 Grand Blanc, Michigan, United States

Site Reference ID/Investigator# 10541; 🇺🇸 Fridley, Minnesota, United States

Site Reference ID/Investigator# 15201; 🇺🇸 Alpharetta, Georgia, United States

Site Reference ID/Investigator# 9901; 🇺🇸 Miami, Florida, United States

Site Reference ID/Investigator# 9984; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 10605; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 9785; 🇺🇸 San Diego, California, United States

Site Reference ID/Investigator# 10264; 🇺🇸 San Antonio, Texas, United States

Site Reference ID/Investigator# 10182; 🇺🇸 Seattle, Washington, United States

Site Reference ID/Investigator# 9790; 🇺🇸 Owensboro, Kentucky, United States

Site Reference ID/Investigator# 10606; 🇺🇸 Omaha, Nebraska, United States

Site Reference ID/Investigator# 10644; 🇺🇸 Omaha, Nebraska, United States

Site Reference ID/Investigator# 10321; 🇺🇸 Milwaukee, Wisconsin, United States

Site Reference ID/Investigator# 9985; 🇺🇸 Bakersfield, California, United States

Site Reference ID/Investigator# 10503; 🇺🇸 Jacksonville, Florida, United States

Site Reference ID/Investigator# 10642; 🇺🇸 Vallejo, California, United States

Site Reference ID/Investigator# 9789; 🇺🇸 Snellville, Georgia, United States

Site Reference ID/Investigator# 15750; 🇺🇸 Owensboro, Kentucky, United States

Site Reference ID/Investigator# 9786; 🇺🇸 Berlin, New Jersey, United States

Site Reference ID/Investigator# 9787; 🇺🇸 Rochester, New York, United States

Site Reference ID/Investigator# 10581; 🇺🇸 Wilmington, North Carolina, United States

Site Reference ID/Investigator# 9982; 🇺🇸 Webster, Texas, United States

Site Reference ID/Investigator# 10643; 🇺🇸 Knoxville, Tennessee, United States

Site Reference ID/Investigator# 9902; 🇺🇸 Hickory, North Carolina, United States

Site Reference ID/Investigator# 10266; 🇺🇸 Miami, Florida, United States

Site Reference ID/Investigator# 10263; 🇺🇸 New Haven, Connecticut, United States

Site Reference ID/Investigator# 10265; 🇺🇸 Louisville, Kentucky, United States

Site Reference ID/Investigator# 10262; 🇺🇸 Newnan, Georgia, United States