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

NCT ID: NCT00691964

Last Updated: 2013-01-21

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

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

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.

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# 8458

Goodlettsville, Tennessee, United States

Site Status

Site Reference ID/Investigator# 8478

Tucson, Arizona, United States

Site Status

Site Reference ID/Investigator# 8462

Fresno, California, United States

Site Status

Site Reference ID/Investigator# 8454

Los Angeles, California, United States

Site Status

Site Reference ID/Investigator# 8476

Denver, Colorado, United States

Site Status

Site Reference ID/Investigator# 9641

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 8463

Alpharetta, Georgia, United States

Site Status

Site Reference ID/Investigator# 8479

Arlington Heights, Illinois, United States

Site Status

Site Reference ID/Investigator# 8527

Schaumburg, Illinois, United States

Site Status

Site Reference ID/Investigator# 9001

Skokie, Illinois, United States

Site Status

Site Reference ID/Investigator# 8466

West Dundee, Illinois, United States

Site Status

Site Reference ID/Investigator# 8467

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 8464

Boston, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 8459

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 8473

East Windsor, New Jersey, United States

Site Status

Site Reference ID/Investigator# 8457

New Brunswick, New Jersey, United States

Site Status

Site Reference ID/Investigator# 8447

Albuquerque, New Mexico, United States

Site Status

Site Reference ID/Investigator# 8475

New York, New York, United States

Site Status

Site Reference ID/Investigator# 8468

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 8460

Cleveland, Ohio, United States

Site Status

Site Reference ID/Investigator# 9762

Oklahoma City, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 8480

Lake Oswego, Oregon, United States

Site Status

Site Reference ID/Investigator# 8469

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 9566

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 9761

Hershey, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 8471

Philadelphia, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 8449

Johnston, Rhode Island, United States

Site Status

Site Reference ID/Investigator# 8448

Providence, Rhode Island, United States

Site Status

Site Reference ID/Investigator# 8456

Greer, South Carolina, United States

Site Status

Site Reference ID/Investigator# 8461

Austin, Texas, United States

Site Status

Site Reference ID/Investigator# 10542

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 8452

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 8474

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 8482

Tyler, Texas, United States

Site Status

Site Reference ID/Investigator# 8472

Norfolk, Virginia, 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.

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.

Reference Type DERIVED
PMID: 21574983 (View on PubMed)

Other Identifiers

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

M10-114

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Acitretin and Etanercept in Psoriasis
NCT00156247 COMPLETED PHASE2