A Study to Evaluate Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE) - Full Text View

A Study to Evaluate Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)

This study is currently recruiting participants.
Verified by Genentech, May 2008

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00096928

Purpose

This is a multicenter, prospective, 5-year surveillance study of approximately 5000 Raptiva-treated patients and approximately 500 non Raptiva treated patients (formerly 2500 comparison patients who were treated with a biologic therapy other than Raptiva) with chronic moderate to severe plaque psoriasis who are candidates for treatment with Raptiva.

Condition	Phase
Psoriasis	Phase IV

MedlinePlus related topics:

Psoriasis

ChemIDplus related topics:

Efalizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Official Title:	Raptiva Epidemiologic Study of Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)

Further study details as provided by Genentech:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	5500
Study Start Date:	March 2005

Groups/Cohorts

Raptiva-treated patients

Non Raptiva-treated patients

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

managed care organizations, community or physician practices, and academic centers in the United States

Criteria

Inclusion Criteria:

Have ever had a physician's diagnosis of chronic moderate to severe plaque psoriasis and be a candidate for treatment with Raptiva
Are being treated with or initiating Raptiva therapy at the time of enrollment
Be able to provide written informed consent
Be willing and able to fully to participate for the duration of patient follow-up (5 years)

Exclusion Criterion:

Have previously received at least one dose of Raptiva and are not currently using or restarting treatment with Raptiva at the time of enrollment

Notes:

If you are a doctor who is interested in participating as a study site, contact the RESPONSE Registry hotline for more information.

If you are an interested patient, contact your dermatologist (or the doctor treating your psoriasis) regarding this study. A list of participating doctors is below. If your doctor is not listed, then he/she can call the RESPONSE Registry Hotline at 1-800-516-1505 for more information.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096928

Contacts


Contact: RESPONSE Registry Hotline	800-516-1505

Show 185 Study Locations

Sponsors and Collaborators

Genentech

Investigators


Study Director:	Ivor Caro, M.D.	Genentech

More Information

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	ACD3101g
First Received:	November 17, 2004
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00096928
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Plaque Psoriasis

RESPONSE

Raptiva

efalizumab

Study placed in the following topic categories:

Skin Diseases

Psoriasis

Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on September 05, 2008