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

This study has been completed.

First Received on November 17, 2004. Last Updated on March 11, 2011 History of Changes

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

Purpose

This was 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 were candidates for treatment with Raptiva.

Condition	Phase
Psoriasis	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: 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:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Efalizumab

U.S. FDA Resources

Further study details as provided by Genentech:

Enrollment:	1846
Study Start Date:	March 2005
Study Completion Date:	October 2009

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

Contacts and Locations

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

Show 182 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Ivor Caro, M.D.

Genentech

More Information

Additional Information:

Clinical Study Report Synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00096928 History of Changes
Other Study ID Numbers:	ACD3101g
Study First Received:	November 17, 2004
Last Updated:	March 11, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Plaque Psoriasis
RESPONSE
Raptiva
efalizumab

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012