Trial record 1 of 13 for:    raptiva for chronic moderate to severe plaque psoriasis
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A Study to Evaluate Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00096928
First received: November 17, 2004
Last updated: March 11, 2011
Last verified: March 2011
  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 4

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:


Further study details as provided by Genentech, Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 182 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Ivor Caro, M.D. Genentech, Inc.
  More Information

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, Inc.:
Plaque Psoriasis
RESPONSE
Raptiva
efalizumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 20, 2014