Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

August 28, 2007 updated by: Abbott

A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects With Moderate to Severe Chronic Plaque Psoriasis

A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Study Overview

Status

Completed

Conditions

Psoriasis

Intervention / Treatment

Drug: adalimumab

Study Type

Interventional

Enrollment (Actual)

1212

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
Subject had a clinical diagnosis of psoriasis for at least 6 months, had moderate to severe plaque psoriasis.
Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections

Exclusion Criteria:

Subject had previously received anti-TNF therapy.
Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
Subject cannot avoid excessive sun exposure
Subject is taking or requires oral or injectable corticosteroids
Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Female subject who is pregnant or breast-feeding or considering becoming pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score Time Frame: Week 16	Week 16

Secondary Outcome Measures

Outcome Measure
Safety parameters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 11, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Estimate)

August 29, 2007

Last Update Submitted That Met QC Criteria

August 28, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M03-656

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.