Clinical trial NCT00710580: Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Paragon Biomedical
First posted: 2008-07-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
timeFrame: 12 Weeks
measure: Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12
timeFrame: 12 Weeks
Secondary outcomes:
measure: Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 9984
state: Alabama
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 10605
state: Alabama
city: Scottsdale
country: United States
facility: Site Reference ID/Investigator# 10001
state: Arizona
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 10502
state: Arkansas
city: Bakersfield
country: United States
facility: Site Reference ID/Investigator# 9985
state: California
city: Irvine
country: United States
facility: Site Reference ID/Investigator# 10661
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 14701
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 9785
state: California
city: Santa Monica
country: United States
facility: Site Reference ID/Investigator# 10662
state: California
city: Vallejo
country: United States
facility: Site Reference ID/Investigator# 10642
state: California
city: New Haven
country: United States
facility: Site Reference ID/Investigator# 10263
state: Connecticut
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 10503
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 10266
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 9901
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 10501
state: Florida
city: Alpharetta
country: United States
facility: Site Reference ID/Investigator# 15201
state: Georgia
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 10762
state: Georgia
city: Newnan
country: United States
facility: Site Reference ID/Investigator# 10262
state: Georgia
city: Snellville
country: United States
facility: Site Reference ID/Investigator# 9789
state: Georgia
city: Maywood
country: United States
facility: Site Reference ID/Investigator# 10666
state: Illinois
city: Plainfield
country: United States
facility: Site Reference ID/Investigator# 15142
state: Indiana
city: Louisville
country: United States
facility: Site Reference ID/Investigator# 10265
state: Kentucky
city: Owensboro
country: United States
facility: Site Reference ID/Investigator# 15750
state: Kentucky
city: Owensboro
country: United States
facility: Site Reference ID/Investigator# 9790
state: Kentucky
city: Fort Gratiot
country: United States
facility: Site Reference ID/Investigator# 9788
state: Michigan
city: Grand Blanc
country: United States
facility: Site Reference ID/Investigator# 10604
state: Michigan
city: Fridley
country: United States
facility: Site Reference ID/Investigator# 10541
state: Minnesota
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 10641
state: Missouri
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 10606
state: Nebraska
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 10644
state: Nebraska
city: Berlin
country: United States
facility: Site Reference ID/Investigator# 9786
state: New Jersey
city: New York
country: United States
facility: Site Reference ID/Investigator# 10241
state: New York
city: Rochester
country: United States
facility: Site Reference ID/Investigator# 9787
state: New York
city: Hickory
country: United States
facility: Site Reference ID/Investigator# 9902
state: North Carolina
city: Wilmington
country: United States
facility: Site Reference ID/Investigator# 10581
state: North Carolina
city: Dayton
country: United States
facility: Site Reference ID/Investigator# 10504
state: Ohio
city: Knoxville
country: United States
facility: Site Reference ID/Investigator# 10643
state: Tennessee
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 9981
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 10264
state: Texas
city: Webster
country: United States
facility: Site Reference ID/Investigator# 9982
state: Texas
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 10182
state: Washington
city: Milwaukee
country: United States
facility: Site Reference ID/Investigator# 10321
state: Wisconsin
Study officials:
affiliation: AbbVie
name: Martin Kaul, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1111/j.1365-2133.2011.10419.x. Epub 2011 Jul 28.