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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

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 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# 8478
  • Site Reference ID/Investigator# 8462
  • Site Reference ID/Investigator# 8454
  • Site Reference ID/Investigator# 8476
  • Site Reference ID/Investigator# 9641
  • Site Reference ID/Investigator# 8463
  • Site Reference ID/Investigator# 8479
  • Site Reference ID/Investigator# 8527
  • Site Reference ID/Investigator# 9001
  • Site Reference ID/Investigator# 8466
  • Site Reference ID/Investigator# 8467
  • Site Reference ID/Investigator# 8464
  • Site Reference ID/Investigator# 8459
  • Site Reference ID/Investigator# 8473
  • Site Reference ID/Investigator# 8457
  • Site Reference ID/Investigator# 8447
  • Site Reference ID/Investigator# 8475
  • Site Reference ID/Investigator# 8468
  • Site Reference ID/Investigator# 8460
  • Site Reference ID/Investigator# 9762
  • Site Reference ID/Investigator# 8480
  • Site Reference ID/Investigator# 8469
  • Site Reference ID/Investigator# 9566
  • Site Reference ID/Investigator# 9761
  • Site Reference ID/Investigator# 8471
  • Site Reference ID/Investigator# 8449
  • Site Reference ID/Investigator# 8448
  • Site Reference ID/Investigator# 8456
  • Site Reference ID/Investigator# 8458
  • Site Reference ID/Investigator# 8461
  • Site Reference ID/Investigator# 10542
  • Site Reference ID/Investigator# 8452
  • Site Reference ID/Investigator# 8474
  • Site Reference ID/Investigator# 8482
  • Site Reference ID/Investigator# 8472

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
June 4, 2008
Last Updated
January 11, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Paragon Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT00691964
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, 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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 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
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
347 (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# 8478
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Site Reference ID/Investigator# 8462
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Site Reference ID/Investigator# 8454
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Site Reference ID/Investigator# 8476
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Site Reference ID/Investigator# 9641
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site Reference ID/Investigator# 8463
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Site Reference ID/Investigator# 8479
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Site Reference ID/Investigator# 8527
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Site Reference ID/Investigator# 9001
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Site Reference ID/Investigator# 8466
City
West Dundee
State/Province
Illinois
ZIP/Postal Code
60118
Country
United States
Facility Name
Site Reference ID/Investigator# 8467
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Site Reference ID/Investigator# 8464
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Site Reference ID/Investigator# 8459
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Site Reference ID/Investigator# 8473
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Site Reference ID/Investigator# 8457
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Site Reference ID/Investigator# 8447
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Site Reference ID/Investigator# 8475
City
New York
State/Province
New York
ZIP/Postal Code
10029-6501
Country
United States
Facility Name
Site Reference ID/Investigator# 8468
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site Reference ID/Investigator# 8460
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Site Reference ID/Investigator# 9762
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Site Reference ID/Investigator# 8480
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Site Reference ID/Investigator# 8469
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Site Reference ID/Investigator# 9566
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Site Reference ID/Investigator# 9761
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Site Reference ID/Investigator# 8471
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Site Reference ID/Investigator# 8449
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Site Reference ID/Investigator# 8448
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Site Reference ID/Investigator# 8456
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Site Reference ID/Investigator# 8458
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Site Reference ID/Investigator# 8461
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Site Reference ID/Investigator# 10542
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-1613
Country
United States
Facility Name
Site Reference ID/Investigator# 8452
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site Reference ID/Investigator# 8474
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 8482
City
Tyler
State/Province
Texas
ZIP/Postal Code
75703
Country
United States
Facility Name
Site Reference ID/Investigator# 8472
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21574983
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.
Results Reference
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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

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