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

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:

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

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

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

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Locations

United States, Alabama
Site Reference ID/Investigator# 9984
Birmingham, Alabama, United States, 35205
Site Reference ID/Investigator# 10605
Birmingham, Alabama, United States, 35233
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# 9790
Owensboro, Kentucky, United States, 42303
Site Reference ID/Investigator# 15750
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# 10606
Omaha, Nebraska, United States, 68131
Site Reference ID/Investigator# 10644
Omaha, Nebraska, United States, 68144
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):

Strober BE, Crowley JJ, Yamauchi PS, Olds M, Williams DA. Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol. 2011 Sep;165(3):661-8. Epub 2011 Jul 28.

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, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013