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

This study has been completed.
Sponsor:
Collaborator:
Paragon Biomedical
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00710580
First received: July 2, 2008
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Moderate to Severe Plaque Psoriasis
Biological: ABT-874
Biological: etanercept
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: July 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Biological: ABT-874
SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
Active Comparator: B Biological: etanercept
SQ injection 50 mg BIW
Placebo Comparator: C Drug: placebo
SQ placebo injections for ABT-874 and etanercept

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710580

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 10605
Birmingham, Alabama, United States, 35233
Site Reference ID/Investigator# 9984
Birmingham, Alabama, United States, 35205
United States, Arizona
Site Reference ID/Investigator# 10001
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Site Reference ID/Investigator# 10502
Little Rock, Arkansas, United States, 72205
United States, California
Site Reference ID/Investigator# 9985
Bakersfield, California, United States, 93309
Site Reference ID/Investigator# 10661
Irvine, California, United States, 92697
Site Reference ID/Investigator# 14701
Los Angeles, California, United States, 90045
Site Reference ID/Investigator# 9785
San Diego, California, United States, 92123
Site Reference ID/Investigator# 10662
Santa Monica, California, United States, 90404
Site Reference ID/Investigator# 10642
Vallejo, California, United States, 94589
United States, Connecticut
Site Reference ID/Investigator# 10263
New Haven, Connecticut, United States, 06511
United States, Florida
Site Reference ID/Investigator# 10503
Jacksonville, Florida, United States, 32204
Site Reference ID/Investigator# 10266
Miami, Florida, United States, 33144
Site Reference ID/Investigator# 9901
Miami, Florida, United States, 33173
Site Reference ID/Investigator# 10501
West Palm Beach, Florida, United States, 33407
United States, Georgia
Site Reference ID/Investigator# 15201
Alpharetta, Georgia, United States, 30022
Site Reference ID/Investigator# 10762
Atlanta, Georgia, United States, 30327
Site Reference ID/Investigator# 10262
Newnan, Georgia, United States, 30263
Site Reference ID/Investigator# 9789
Snellville, Georgia, United States, 30078
United States, Illinois
Site Reference ID/Investigator# 10666
Maywood, Illinois, United States, 60153
United States, Indiana
Site Reference ID/Investigator# 15142
Plainfield, Indiana, United States, 46168
United States, Kentucky
Site Reference ID/Investigator# 10265
Louisville, Kentucky, United States, 40202
Site Reference ID/Investigator# 15750
Owensboro, Kentucky, United States, 42303
Site Reference ID/Investigator# 9790
Owensboro, Kentucky, United States, 42303
United States, Michigan
Site Reference ID/Investigator# 9788
Fort Gratiot, Michigan, United States, 48059
Site Reference ID/Investigator# 10604
Grand Blanc, Michigan, United States, 48439
United States, Minnesota
Site Reference ID/Investigator# 10541
Fridley, Minnesota, United States, 55432
United States, Missouri
Site Reference ID/Investigator# 10641
St. Louis, Missouri, United States, 63110
United States, Nebraska
Site Reference ID/Investigator# 10644
Omaha, Nebraska, United States, 68144
Site Reference ID/Investigator# 10606
Omaha, Nebraska, United States, 68131
United States, New Jersey
Site Reference ID/Investigator# 9786
Berlin, New Jersey, United States, 08009
United States, New York
Site Reference ID/Investigator# 10241
New York, New York, United States, 10016
Site Reference ID/Investigator# 9787
Rochester, New York, United States, 14623
United States, North Carolina
Site Reference ID/Investigator# 9902
Hickory, North Carolina, United States, 28601
Site Reference ID/Investigator# 10581
Wilmington, North Carolina, United States, 28401
United States, Ohio
Site Reference ID/Investigator# 10504
Dayton, Ohio, United States, 45408
United States, Tennessee
Site Reference ID/Investigator# 10643
Knoxville, Tennessee, United States, 37934
United States, Texas
Site Reference ID/Investigator# 9981
Dallas, Texas, United States, 75230
Site Reference ID/Investigator# 10264
San Antonio, Texas, United States, 78229
Site Reference ID/Investigator# 9982
Webster, Texas, United States, 77598
United States, Washington
Site Reference ID/Investigator# 10182
Seattle, Washington, United States, 98101
United States, Wisconsin
Site Reference ID/Investigator# 10321
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Paragon Biomedical
Investigators
Study Director: Martin Kaul, MD AbbVie
  More Information

No publications provided by AbbVie

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00710580     History of Changes
Other Study ID Numbers: M10-315
Study First Received: July 2, 2008
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014