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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

Primary Purpose

Moderate to Severe Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABT-874
etanercept
placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 9984
  • Site Reference ID/Investigator# 10605
  • Site Reference ID/Investigator# 10001
  • Site Reference ID/Investigator# 10502
  • Site Reference ID/Investigator# 9985
  • Site Reference ID/Investigator# 10661
  • Site Reference ID/Investigator# 14701
  • Site Reference ID/Investigator# 9785
  • Site Reference ID/Investigator# 10662
  • Site Reference ID/Investigator# 10642
  • Site Reference ID/Investigator# 10263
  • Site Reference ID/Investigator# 10503
  • Site Reference ID/Investigator# 10266
  • Site Reference ID/Investigator# 9901
  • Site Reference ID/Investigator# 10501
  • Site Reference ID/Investigator# 15201
  • Site Reference ID/Investigator# 10762
  • Site Reference ID/Investigator# 10262
  • Site Reference ID/Investigator# 9789
  • Site Reference ID/Investigator# 10666
  • Site Reference ID/Investigator# 15142
  • Site Reference ID/Investigator# 10265
  • Site Reference ID/Investigator# 15750
  • Site Reference ID/Investigator# 9790
  • Site Reference ID/Investigator# 9788
  • Site Reference ID/Investigator# 10604
  • Site Reference ID/Investigator# 10541
  • Site Reference ID/Investigator# 10641
  • Site Reference ID/Investigator# 10606
  • Site Reference ID/Investigator# 10644
  • Site Reference ID/Investigator# 9786
  • Site Reference ID/Investigator# 10241
  • Site Reference ID/Investigator# 9787
  • Site Reference ID/Investigator# 9902
  • Site Reference ID/Investigator# 10581
  • Site Reference ID/Investigator# 10504
  • Site Reference ID/Investigator# 10643
  • Site Reference ID/Investigator# 9981
  • Site Reference ID/Investigator# 10264
  • Site Reference ID/Investigator# 9982
  • Site Reference ID/Investigator# 10182
  • Site Reference ID/Investigator# 10321

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

A

B

C

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12

Secondary Outcome Measures

Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12

Full Information

First Posted
July 2, 2008
Last Updated
January 10, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Paragon Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT00710580
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Paragon Biomedical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
ABT-874
Intervention Description
SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
Intervention Type
Biological
Intervention Name(s)
etanercept
Intervention Description
SQ injection 50 mg BIW
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
SQ placebo injections for ABT-874 and etanercept
Primary Outcome Measure Information:
Title
Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
Time Frame
12 Weeks
Title
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Kaul, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 9984
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Site Reference ID/Investigator# 10605
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Site Reference ID/Investigator# 10001
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Site Reference ID/Investigator# 10502
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Site Reference ID/Investigator# 9985
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Site Reference ID/Investigator# 10661
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Site Reference ID/Investigator# 14701
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Site Reference ID/Investigator# 9785
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site Reference ID/Investigator# 10662
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Site Reference ID/Investigator# 10642
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Site Reference ID/Investigator# 10263
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Site Reference ID/Investigator# 10503
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Site Reference ID/Investigator# 10266
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Site Reference ID/Investigator# 9901
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Site Reference ID/Investigator# 10501
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Site Reference ID/Investigator# 15201
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Site Reference ID/Investigator# 10762
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Site Reference ID/Investigator# 10262
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Site Reference ID/Investigator# 9789
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Site Reference ID/Investigator# 10666
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Site Reference ID/Investigator# 15142
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Site Reference ID/Investigator# 10265
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Site Reference ID/Investigator# 15750
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Site Reference ID/Investigator# 9790
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Site Reference ID/Investigator# 9788
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Site Reference ID/Investigator# 10604
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Site Reference ID/Investigator# 10541
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Site Reference ID/Investigator# 10641
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site Reference ID/Investigator# 10606
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Site Reference ID/Investigator# 10644
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Site Reference ID/Investigator# 9786
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Site Reference ID/Investigator# 10241
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Site Reference ID/Investigator# 9787
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Site Reference ID/Investigator# 9902
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Site Reference ID/Investigator# 10581
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Site Reference ID/Investigator# 10504
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Site Reference ID/Investigator# 10643
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Site Reference ID/Investigator# 9981
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Site Reference ID/Investigator# 10264
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 9982
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Site Reference ID/Investigator# 10182
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Site Reference ID/Investigator# 10321
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21574984
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.
Results Reference
derived

Learn more about this trial

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

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