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

This study is ongoing, but not recruiting participants.

First Received: November 17, 2004 Last Updated: April 10, 2009 History of Changes

Sponsor:	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

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Raptiva Epidemiologic Study of Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Efalizumab

U.S. FDA Resources

Further study details as provided by Genentech:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	5500
Study Start Date:	March 2005

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

Show 183 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Ivor Caro, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	ACD3101g
Study First Received:	November 17, 2004
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00096928 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Plaque Psoriasis
RESPONSE
Raptiva
efalizumab

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on February 08, 2010