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

NCT ID: NCT00710580

Last Updated: 2013-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Moderate to Severe Plaque Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

ABT-874

Intervention Type BIOLOGICAL

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

B

Group Type ACTIVE_COMPARATOR

etanercept

Intervention Type BIOLOGICAL

SQ injection 50 mg BIW

C

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

SQ placebo injections for ABT-874 and etanercept

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABT-874

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

Intervention Type BIOLOGICAL

etanercept

SQ injection 50 mg BIW

Intervention Type BIOLOGICAL

placebo

SQ placebo injections for ABT-874 and etanercept

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Paragon Biomedical

INDUSTRY

Sponsor Role collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Kaul, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 9984

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 10605

Birmingham, Alabama, United States

Site Status

Site Reference ID/Investigator# 10001

Scottsdale, Arizona, United States

Site Status

Site Reference ID/Investigator# 10502

Little Rock, Arkansas, United States

Site Status

Site Reference ID/Investigator# 9985

Bakersfield, California, United States

Site Status

Site Reference ID/Investigator# 10661

Irvine, California, United States

Site Status

Site Reference ID/Investigator# 14701

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 9785

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 10662

Santa Monica, California, United States

Site Status

Site Reference ID/Investigator# 10642

Vallejo, California, United States

Site Status

Site Reference ID/Investigator# 10263

New Haven, Connecticut, United States

Site Status

Site Reference ID/Investigator# 10503

Jacksonville, Florida, United States

Site Status

Site Reference ID/Investigator# 10266

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 9901

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 10501

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 15201

Alpharetta, Georgia, United States

Site Status

Site Reference ID/Investigator# 10762

Atlanta, Georgia, United States

Site Status

Site Reference ID/Investigator# 10262

Newnan, Georgia, United States

Site Status

Site Reference ID/Investigator# 9789

Snellville, Georgia, United States

Site Status

Site Reference ID/Investigator# 10666

Maywood, Illinois, United States

Site Status

Site Reference ID/Investigator# 15142

Plainfield, Indiana, United States

Site Status

Site Reference ID/Investigator# 10265

Louisville, Kentucky, United States

Site Status

Site Reference ID/Investigator# 15750

Owensboro, Kentucky, United States

Site Status

Site Reference ID/Investigator# 9790

Owensboro, Kentucky, United States

Site Status

Site Reference ID/Investigator# 9788

Fort Gratiot, Michigan, United States

Site Status

Site Reference ID/Investigator# 10604

Grand Blanc, Michigan, United States

Site Status

Site Reference ID/Investigator# 10541

Fridley, Minnesota, United States

Site Status

Site Reference ID/Investigator# 10641

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 10606

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 10644

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 9786

Berlin, New Jersey, United States

Site Status

Site Reference ID/Investigator# 10241

New York, New York, United States

Site Status

Site Reference ID/Investigator# 9787

Rochester, New York, United States

Site Status

Site Reference ID/Investigator# 9902

Hickory, North Carolina, United States

Site Status

Site Reference ID/Investigator# 10581

Wilmington, North Carolina, United States

Site Status

Site Reference ID/Investigator# 10504

Dayton, Ohio, United States

Site Status

Site Reference ID/Investigator# 10643

Knoxville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 9981

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 10264

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 9982

Webster, Texas, United States

Site Status

Site Reference ID/Investigator# 10182

Seattle, Washington, United States

Site Status

Site Reference ID/Investigator# 10321

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21574984 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M10-315

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.