Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
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
1 other identifier
interventional
347
1 country
35
Brief Summary
Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2008
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJanuary 21, 2013
January 1, 2013
10 months
June 4, 2008
January 11, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
12 Weeks
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12
12 Weeks
Secondary Outcomes (1)
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12
12 Weeks
Study Arms (3)
A
EXPERIMENTALB
ACTIVE COMPARATORC
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Psoriasis for 6 mo.
- BSA 10%, PASI 12 or above, PGA 3 or above
You may not qualify if:
- Previous exposure to either etanercept or ABT-874
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVie (prior sponsor, Abbott)lead
- Paragon Biomedicalcollaborator
Study Sites (35)
Site Reference ID/Investigator# 8478
Tucson, Arizona, 85710, United States
Site Reference ID/Investigator# 8462
Fresno, California, 93720, United States
Site Reference ID/Investigator# 8454
Los Angeles, California, 90045, United States
Site Reference ID/Investigator# 8476
Denver, Colorado, 80209, United States
Site Reference ID/Investigator# 9641
Miami, Florida, 33136, United States
Site Reference ID/Investigator# 8463
Alpharetta, Georgia, 30022, United States
Site Reference ID/Investigator# 8479
Arlington Heights, Illinois, 60005, United States
Site Reference ID/Investigator# 8527
Schaumburg, Illinois, 60194, United States
Site Reference ID/Investigator# 9001
Skokie, Illinois, 60077, United States
Site Reference ID/Investigator# 8466
West Dundee, Illinois, 60118, United States
Site Reference ID/Investigator# 8467
Indianapolis, Indiana, 46256, United States
Site Reference ID/Investigator# 8464
Boston, Massachusetts, 02111, United States
Site Reference ID/Investigator# 8459
St Louis, Missouri, 63117, United States
Site Reference ID/Investigator# 8473
East Windsor, New Jersey, 08520, United States
Site Reference ID/Investigator# 8457
New Brunswick, New Jersey, 08903, United States
Site Reference ID/Investigator# 8447
Albuquerque, New Mexico, 87106, United States
Site Reference ID/Investigator# 8475
New York, New York, 10029-6501, United States
Site Reference ID/Investigator# 8468
Cincinnati, Ohio, 45219, United States
Site Reference ID/Investigator# 8460
Cleveland, Ohio, 44106, United States
Site Reference ID/Investigator# 9762
Oklahoma City, Oklahoma, 73104, United States
Site Reference ID/Investigator# 8480
Lake Oswego, Oregon, 97035, United States
Site Reference ID/Investigator# 8469
Portland, Oregon, 97210, United States
Site Reference ID/Investigator# 9566
Portland, Oregon, 97223, United States
Site Reference ID/Investigator# 9761
Hershey, Pennsylvania, 17033, United States
Site Reference ID/Investigator# 8471
Philadelphia, Pennsylvania, 19103, United States
Site Reference ID/Investigator# 8449
Johnston, Rhode Island, 02919, United States
Site Reference ID/Investigator# 8448
Providence, Rhode Island, 02903, United States
Site Reference ID/Investigator# 8456
Greer, South Carolina, 29651, United States
Site Reference ID/Investigator# 8458
Goodlettsville, Tennessee, 37072, United States
Site Reference ID/Investigator# 8461
Austin, Texas, 78759, United States
Site Reference ID/Investigator# 10542
Dallas, Texas, 75246-1613, United States
Site Reference ID/Investigator# 8452
Houston, Texas, 77030, United States
Site Reference ID/Investigator# 8474
San Antonio, Texas, 78229, United States
Site Reference ID/Investigator# 8482
Tyler, Texas, 75703, United States
Site Reference ID/Investigator# 8472
Norfolk, Virginia, 23507, United States
Related Publications (1)
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.
PMID: 21574983DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martin Kaul, MD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 6, 2008
Study Start
May 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
January 21, 2013
Record last verified: 2013-01