NCT00710580

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

42 active sites

Status
completed

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

July 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 18, 2013

Status Verified

January 1, 2013

Enrollment Period

9 months

First QC Date

July 2, 2008

Last Update Submit

January 10, 2013

Conditions

Moderate to Severe Plaque Psoriasis

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

EXPERIMENTAL
Biological: ABT-874

B

ACTIVE COMPARATOR
Biological: etanercept

C

PLACEBO COMPARATOR
Drug: placebo

Interventions

ABT-874BIOLOGICAL

SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8

A
etanerceptBIOLOGICAL

SQ injection 50 mg BIW

B
placeboDRUG

SQ placebo injections for ABT-874 and etanercept

C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (42)

Site Reference ID/Investigator# 9984

Birmingham, Alabama, 35205, United States

Location

Site Reference ID/Investigator# 10605

Birmingham, Alabama, 35233, United States

Location

Site Reference ID/Investigator# 10001

Scottsdale, Arizona, 85251, United States

Location

Site Reference ID/Investigator# 10502

Little Rock, Arkansas, 72205, United States

Location

Site Reference ID/Investigator# 9985

Bakersfield, California, 93309, United States

Location

Site Reference ID/Investigator# 10661

Irvine, California, 92697, United States

Location

Site Reference ID/Investigator# 14701

Los Angeles, California, 90045, United States

Location

Site Reference ID/Investigator# 9785

San Diego, California, 92123, United States

Location

Site Reference ID/Investigator# 10662

Santa Monica, California, 90404, United States

Location

Site Reference ID/Investigator# 10642

Vallejo, California, 94589, United States

Location

Site Reference ID/Investigator# 10263

New Haven, Connecticut, 06511, United States

Location

Site Reference ID/Investigator# 10503

Jacksonville, Florida, 32204, United States

Location

Site Reference ID/Investigator# 10266

Miami, Florida, 33144, United States

Location

Site Reference ID/Investigator# 9901

Miami, Florida, 33173, United States

Location

Site Reference ID/Investigator# 10501

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 15201

Alpharetta, Georgia, 30022, United States

Location

Site Reference ID/Investigator# 10762

Atlanta, Georgia, 30327, United States

Location

Site Reference ID/Investigator# 10262

Newnan, Georgia, 30263, United States

Location

Site Reference ID/Investigator# 9789

Snellville, Georgia, 30078, United States

Location

Site Reference ID/Investigator# 10666

Maywood, Illinois, 60153, United States

Location

Site Reference ID/Investigator# 15142

Plainfield, Indiana, 46168, United States

Location

Site Reference ID/Investigator# 10265

Louisville, Kentucky, 40202, United States

Location

Site Reference ID/Investigator# 15750

Owensboro, Kentucky, 42303, United States

Location

Site Reference ID/Investigator# 9790

Owensboro, Kentucky, 42303, United States

Location

Site Reference ID/Investigator# 9788

Fort Gratiot, Michigan, 48059, United States

Location

Site Reference ID/Investigator# 10604

Grand Blanc, Michigan, 48439, United States

Location

Site Reference ID/Investigator# 10541

Fridley, Minnesota, 55432, United States

Location

Site Reference ID/Investigator# 10641

St Louis, Missouri, 63110, United States

Location

Site Reference ID/Investigator# 10606

Omaha, Nebraska, 68131, United States

Location

Site Reference ID/Investigator# 10644

Omaha, Nebraska, 68144, United States

Location

Site Reference ID/Investigator# 9786

Berlin, New Jersey, 08009, United States

Location

Site Reference ID/Investigator# 10241

New York, New York, 10016, United States

Location

Site Reference ID/Investigator# 9787

Rochester, New York, 14623, United States

Location

Site Reference ID/Investigator# 9902

Hickory, North Carolina, 28601, United States

Location

Site Reference ID/Investigator# 10581

Wilmington, North Carolina, 28401, United States

Location

Site Reference ID/Investigator# 10504

Dayton, Ohio, 45408, United States

Location

Site Reference ID/Investigator# 10643

Knoxville, Tennessee, 37934, United States

Location

Site Reference ID/Investigator# 9981

Dallas, Texas, 75230, United States

Location

Site Reference ID/Investigator# 10264

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 9982

Webster, Texas, 77598, United States

Location

Site Reference ID/Investigator# 10182

Seattle, Washington, 98101, United States

Location

Site Reference ID/Investigator# 10321

Milwaukee, Wisconsin, 53209, United States

Location

Related Publications (1)

  • 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.

    PMID: 21574984DERIVED

MeSH Terms

Interventions

briakinumabEtanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Martin Kaul, MD

    AbbVie

    STUDY DIRECTOR

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

July 2, 2008

First Posted

July 4, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

January 18, 2013

Record last verified: 2013-01

Locations

US(42)