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: Plaque Psoriasis
• Interventions: Biological: ABT-874; Biological: etanercept; Drug: placebo

• Registration Number: NCT00691964
• 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: 2008-05
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Disposition First Submitted: 2011-09-09
• Disposition First Submitted QC: 2011-09-09
• Disposition First Posted: 2011-09-21
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

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 (35)

Site Reference ID/Investigator# 8471; 🇺🇸 Philadelphia, Pennsylvania, United States

Site Reference ID/Investigator# 9641; 🇺🇸 Miami, Florida, United States

Site Reference ID/Investigator# 8464; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 8468; 🇺🇸 Cincinnati, Ohio, United States

Site Reference ID/Investigator# 8460; 🇺🇸 Cleveland, Ohio, United States

Site Reference ID/Investigator# 8479; 🇺🇸 Arlington Heights, Illinois, United States

Site Reference ID/Investigator# 8467; 🇺🇸 Indianapolis, Indiana, United States

Site Reference ID/Investigator# 8478; 🇺🇸 Tucson, Arizona, United States

Site Reference ID/Investigator# 8462; 🇺🇸 Fresno, California, United States

Site Reference ID/Investigator# 8447; 🇺🇸 Albuquerque, New Mexico, United States

Site Reference ID/Investigator# 9762; 🇺🇸 Oklahoma City, Oklahoma, United States

Site Reference ID/Investigator# 8469; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 8454; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator# 8459; 🇺🇸 St. Louis, Missouri, United States

Site Reference ID/Investigator# 9001; 🇺🇸 Skokie, Illinois, United States

Site Reference ID/Investigator# 8473; 🇺🇸 East Windsor, New Jersey, United States

Site Reference ID/Investigator# 8457; 🇺🇸 New Brunswick, New Jersey, United States

Site Reference ID/Investigator# 8475; 🇺🇸 New York, New York, United States

Site Reference ID/Investigator# 8456; 🇺🇸 Greer, South Carolina, United States

Site Reference ID/Investigator# 8458; 🇺🇸 Goodlettsville, Tennessee, United States

Site Reference ID/Investigator# 8461; 🇺🇸 Austin, Texas, United States

Site Reference ID/Investigator# 10542; 🇺🇸 Dallas, Texas, United States

Site Reference ID/Investigator# 8452; 🇺🇸 Houston, Texas, United States

Site Reference ID/Investigator# 8474; 🇺🇸 San Antonio, Texas, United States

Site Reference ID/Investigator# 9566; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 8449; 🇺🇸 Johnston, Rhode Island, United States

Site Reference ID/Investigator# 8448; 🇺🇸 Providence, Rhode Island, United States

Site Reference ID/Investigator# 8463; 🇺🇸 Alpharetta, Georgia, United States

Site Reference ID/Investigator# 8527; 🇺🇸 Schaumburg, Illinois, United States

Site Reference ID/Investigator# 8466; 🇺🇸 West Dundee, Illinois, United States

Site Reference ID/Investigator# 8476; 🇺🇸 Denver, Colorado, United States

Site Reference ID/Investigator# 8480; 🇺🇸 Lake Oswego, Oregon, United States

Site Reference ID/Investigator# 8482; 🇺🇸 Tyler, Texas, United States

Site Reference ID/Investigator# 9761; 🇺🇸 Hershey, Pennsylvania, United States

Site Reference ID/Investigator# 8472; 🇺🇸 Norfolk, Virginia, United States