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NCT00710580 Clinical Trial

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

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:
A Phase 3, Multicenter, 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00710580
Other study ID # M10-315
Secondary ID
Status Completed
Phase Phase 3
First received July 2, 2008
Last updated January 10, 2013
Start date July 2008
Est. completion date April 2009

Study information
Verified date January 2013
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Moderate to Severe Plaque Psoriasis
  • Psoriasis

Intervention

Biological:
• ABT-874
SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
• etanercept
SQ injection 50 mg BIW
Drug:
• placebo
SQ placebo injections for ABT-874 and etanercept

Locations
Country Name City State
United States Site Reference ID/Investigator# 15201 Alpharetta Georgia
United States Site Reference ID/Investigator# 10762 Atlanta Georgia
United States Site Reference ID/Investigator# 9985 Bakersfield California
United States Site Reference ID/Investigator# 9786 Berlin New Jersey
United States Site Reference ID/Investigator# 10605 Birmingham Alabama
United States Site Reference ID/Investigator# 9984 Birmingham Alabama
United States Site Reference ID/Investigator# 9981 Dallas Texas
United States Site Reference ID/Investigator# 10504 Dayton Ohio
United States Site Reference ID/Investigator# 9788 Fort Gratiot Michigan
United States Site Reference ID/Investigator# 10541 Fridley Minnesota
United States Site Reference ID/Investigator# 10604 Grand Blanc Michigan
United States Site Reference ID/Investigator# 9902 Hickory North Carolina
United States Site Reference ID/Investigator# 10661 Irvine California
United States Site Reference ID/Investigator# 10503 Jacksonville Florida
United States Site Reference ID/Investigator# 10643 Knoxville Tennessee
United States Site Reference ID/Investigator# 10502 Little Rock Arkansas
United States Site Reference ID/Investigator# 14701 Los Angeles California
United States Site Reference ID/Investigator# 10265 Louisville Kentucky
United States Site Reference ID/Investigator# 10666 Maywood Illinois
United States Site Reference ID/Investigator# 10266 Miami Florida
United States Site Reference ID/Investigator# 9901 Miami Florida
United States Site Reference ID/Investigator# 10321 Milwaukee Wisconsin
United States Site Reference ID/Investigator# 10263 New Haven Connecticut
United States Site Reference ID/Investigator# 10241 New York New York
United States Site Reference ID/Investigator# 10262 Newnan Georgia
United States Site Reference ID/Investigator# 10606 Omaha Nebraska
United States Site Reference ID/Investigator# 10644 Omaha Nebraska
United States Site Reference ID/Investigator# 15750 Owensboro Kentucky
United States Site Reference ID/Investigator# 9790 Owensboro Kentucky
United States Site Reference ID/Investigator# 15142 Plainfield Indiana
United States Site Reference ID/Investigator# 9787 Rochester New York
United States Site Reference ID/Investigator# 10264 San Antonio Texas
United States Site Reference ID/Investigator# 9785 San Diego California
United States Site Reference ID/Investigator# 10662 Santa Monica California
United States Site Reference ID/Investigator# 10001 Scottsdale Arizona
United States Site Reference ID/Investigator# 10182 Seattle Washington
United States Site Reference ID/Investigator# 9789 Snellville Georgia
United States Site Reference ID/Investigator# 10641 St. Louis Missouri
United States Site Reference ID/Investigator# 10642 Vallejo California
United States Site Reference ID/Investigator# 9982 Webster Texas
United States Site Reference ID/Investigator# 10501 West Palm Beach Florida
United States Site Reference ID/Investigator# 10581 Wilmington North Carolina

Sponsors (2)
Lead Sponsor Collaborator
AbbVie (prior sponsor, Abbott) Paragon Biomedical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 12 Weeks No
Primary Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 12 Weeks No
Secondary Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12 12 Weeks No
See also
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