Clinical trial NCT00691964: 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, Multi-Center, 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: Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Paragon Biomedical
First posted: 2008-06-06
Enrollment: 347
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: Tucson
country: United States
facility: Site Reference ID/Investigator# 8478
state: Arizona
city: Fresno
country: United States
facility: Site Reference ID/Investigator# 8462
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 8454
state: California
city: Denver
country: United States
facility: Site Reference ID/Investigator# 8476
state: Colorado
city: Miami
country: United States
facility: Site Reference ID/Investigator# 9641
state: Florida
city: Alpharetta
country: United States
facility: Site Reference ID/Investigator# 8463
state: Georgia
city: Arlington Heights
country: United States
facility: Site Reference ID/Investigator# 8479
state: Illinois
city: Schaumburg
country: United States
facility: Site Reference ID/Investigator# 8527
state: Illinois
city: Skokie
country: United States
facility: Site Reference ID/Investigator# 9001
state: Illinois
city: West Dundee
country: United States
facility: Site Reference ID/Investigator# 8466
state: Illinois
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 8467
state: Indiana
city: Boston
country: United States
facility: Site Reference ID/Investigator# 8464
state: Massachusetts
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 8459
state: Missouri
city: East Windsor
country: United States
facility: Site Reference ID/Investigator# 8473
state: New Jersey
city: New Brunswick
country: United States
facility: Site Reference ID/Investigator# 8457
state: New Jersey
city: Albuquerque
country: United States
facility: Site Reference ID/Investigator# 8447
state: New Mexico
city: New York
country: United States
facility: Site Reference ID/Investigator# 8475
state: New York
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 8468
state: Ohio
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 8460
state: Ohio
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 9762
state: Oklahoma
city: Lake Oswego
country: United States
facility: Site Reference ID/Investigator# 8480
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 8469
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 9566
state: Oregon
city: Hershey
country: United States
facility: Site Reference ID/Investigator# 9761
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 8471
state: Pennsylvania
city: Johnston
country: United States
facility: Site Reference ID/Investigator# 8449
state: Rhode Island
city: Providence
country: United States
facility: Site Reference ID/Investigator# 8448
state: Rhode Island
city: Greer
country: United States
facility: Site Reference ID/Investigator# 8456
state: South Carolina
city: Goodlettsville
country: United States
facility: Site Reference ID/Investigator# 8458
state: Tennessee
city: Austin
country: United States
facility: Site Reference ID/Investigator# 8461
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 10542
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 8452
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 8474
state: Texas
city: Tyler
country: United States
facility: Site Reference ID/Investigator# 8482
state: Texas
city: Norfolk
country: United States
facility: Site Reference ID/Investigator# 8472
state: Virginia
Study officials:
affiliation: AbbVie
name: Martin Kaul, MD
role: STUDY_DIRECTOR
References:
citation: Gottlieb AB, Leonardi C, Kerdel F, Mehlis S, Olds M, Williams DA. Efficacy and safety of briakinumab vs. etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. Br J Dermatol. 2011 Sep;165(3):652-60. doi: 10.1111/j.1365-2133.2011.10418.x. Epub 2011 Aug 4.