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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 is ongoing, but not recruiting participants.
First Received: November 17, 2004   Last Updated: April 10, 2009   History of Changes
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
Drug Information available for: Efalizumab
U.S. FDA Resources
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)

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

  Hide Study Locations
Locations
United States, Alabama
Deep South Dermatology
Daphne, Alabama, United States, 36526
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
Ruth A. Yates, MD
Huntsville, Alabama, United States, 35801
The Dermatology Center
Gadsden, Alabama, United States, 35901
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States, 35205
United States, Arizona
Alliance Dermatology and MOHS
Phoenix, Arizona, United States, 85032
SunValley Arthritis Center Ltd
Glendale, Arizona, United States, 85308-7100
United States, Arkansas
BGPDS Dermatology
Little Rock, Arkansas, United States, 72205
Hull Dermatology, PA
Rogers, Arkansas, United States, 72758
United States, California
Associates In Research, Inc.
Fresno, California, United States, 93720
Bakersfield Dermatology and Skin Cancer Medical Grp
Bakersfield, California, United States, 93309
Skin Physicians and Surgeons Medical Group, Inc.
Upland, California, United States, 91786
Delta Dermatology Medical Group
Inglewood, California, United States, 90301
Dermatology Associates
Los Angeles, California, United States, 90045
Dermatology Medical Group of Oxnard
Oxnard, California, United States, 93030
East Bay Psoriasis Treatment Center
San Ramon, California, United States, 94583
Elizabeth A. Abel, MD
Mountain View, California, United States, 94040
Fairmont Dermatology Medical Associates, Inc
Lodi, California, United States, 95242
Healthcare Partners Medical Group
Torrance, California, United States, 90503
Kent Carson, MD
San Jose, California, United States, 95123
Minarets Medical Group
Fresno, California, United States, 93711
Clinical Research Specialists, Inc.
Santa Monica, California, United States, 90404
T. Joseph Raoof, MD, Inc.
Encino, California, United States, 91436
United States, Colorado
Centennial Cosmetic Surgery and Dermatology
Centennial, Colorado, United States, 80112
Colorado Medical Research Center, Inc.
Denver, Colorado, United States, 80210
Meridian Skin Cancer Center
Englewood, Colorado, United States, 80112
Northern Colorado Allergy and Asthma Clinic
Greeley, Colorado, United States, 80634
United States, Connecticut
Dermatology Associates Of Western Connecticut
Danbury, Connecticut, United States, 06810
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
Aventura Medical Research Inc
Aventura, Florida, United States, 33180
Brent M Schillinger, MD, PA
Boca Raton, Florida, United States, 33433
Central Florida Dermatology Associates, Inc.
Orlando, Florida, United States, 32806
Clinical Research of Tampa Bay, Inc.
Spring Hill, Florida, United States, 34609
Coastal Dermatology
Jacksonville, Florida, United States, 32246
David Hecker, MD
Boca Raton, Florida, United States, 33496
Dermatology Associates and Research
Coral Gables, Florida, United States, 33134
Dermatology Consultants of Broward
Pembroke Pines, Florida, United States, 33028
Dermatology Research by Dr. Gary L. Heller
Pinellas Park, Florida, United States, 33781
Genesis Dermatology
Jupiter, Florida, United States, 33458
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States, 32204
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
Stephen N Horwitz, MD, PA
Aventura, Florida, United States, 33180
The Dermatology and Aesthetic Center
Boca Raton, Florida, United States, 33486
University of Miami Dept. of Dermatology and Cutaneous Surgery
Miami, Florida, United States, 33136
United States, Georgia
Atlanta Dermatology, Vein, and Research Center, LLC
Alpharetta, Georgia, United States, 30005
Dermatologic Surgery Specialists, Inc.
Macon, Georgia, United States, 31217
Dermatology Specialists of West Georgia
Carrollton, Georgia, United States, 30117
East Metro Dermatology
Conyers, Georgia, United States, 30012
Emory University
Atlanta, Georgia, United States, 30322
Gwinnett Clinical Research Center Inc.
Snellville, Georgia, United States, 30078
Northwest Georgia Dermatology
Rome, Georgia, United States, 30165
Toccoa Clinic Medical Associates
Toccoa, Georgia, United States, 30577
United States, Hawaii
Queens Medical Center
Honolulu, Hawaii, United States, 96813
United States, Idaho
Alan Olmstead, MD
Twin Falls, Idaho, United States, 83301
United States, Illinois
Advanced Dermatology
Lincolnshire, Illinois, United States, 60069
Christie Clinic
Champaign, Illinois, United States, 61820
Danilo V. Del Campo
Chicago, Illinois, United States, 60641
Fox Valley Dermatology LTD
Aurora, Illinois, United States, 60502
Northwestern University
Chicago, Illinois, United States, 60611
Schaumburg Dermatology
Schaumburg, Illinois, United States, 60194
Skin Care Center Of Southern Illinois
Mt Vernon, Illinois, United States, 62864
United States, Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
The Dermatology Center of Indiana
Plainfield, Indiana, United States, 46168
Dermatology Center of Northwest Indiana
Crown Point, Indiana, United States, 46307
Investigators Research Group
Indianapolis, Indiana, United States, 46254
Randall Dermatology, PC
West Lafayette, Indiana, United States, 47906
Dermatology Associates, PC
Indianapolis, Indiana, United States, 46240
The Dermatology Center PSC
New Albany, Indiana, United States, 47150
Three Rivers Dermatology
Ft. Wayne, Indiana, United States, 46804
United States, Iowa
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas City Dermatology, PA
Overland Park, Kansas, United States, 66215
Kansas Medical Clinic
Topeka, Kansas, United States, 66614
United States, Kentucky
Derm Research, PLLC
Louisville, Kentucky, United States, 40217
Graves Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
United States, Louisiana
Dermatology and Advanced Aesthetics
Lake Charles, Louisiana, United States, 70601
Highland Clinic, APMC
Shreveport, Louisiana, United States, 71105
Louisiana Dermatology Associates
Baton Rouge, Louisiana, United States, 70806
United States, Maryland
Callender Skin and Laser Center
Mitchellville, Maryland, United States, 20721
Washington Dermatology Center
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Brigham and Womens' Hospital
Boston, Massachusetts, United States, 02115
Dermatology Associates
Norwood, Massachusetts, United States, 02062
Skin Care Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States, 02467
Worcester Dermatology
Worcester, Massachusetts, United States, 01608
United States, Michigan
David Fivenson, MD Dermatology, PLLC
Ann Arbor, Michigan, United States, 48103
Great Lakes Research Group, Inc.
Bay City, Michigan, United States, 48706
M. Siegel, MD PC
Waterford, Michigan, United States, 48328-3735
Psoriasis and Eczema Treatment Center of Western Michigan PLLC
Grand Rapids, Michigan, United States, 49503
Somerset Skin Centre
Troy, Michigan, United States, 48084
United States, Missouri
Central Dermatology, PC
St. Louis, Missouri, United States, 63117
Jacquelyn B. Garrett
St. Louis, Missouri, United States, 63136
Karen E Forsman, MD Dermatology LLC
St. Louis, Missouri, United States, 63141
Lloyd J. Cleaver, DO, LLC
Kirksville, Missouri, United States, 63501
Saint Louis University
St. Louis, Missouri, United States, 63104
United States, Nebraska
South Lincoln Dermatology
Lincoln, Nebraska, United States, 68502
United States, Nevada
Nevada Center For Dermatology, Ltd
Reno, Nevada, United States, 89511
Skin Cancer and Dermatology Institute
Reno, Nevada, United States, 89511
Woodson Dermatology
Las Vegas, Nevada, United States, 89128
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Nashua Dermatology
Nashua, New Hampshire, United States, 03062
Nashua Dermatology Associates
Nashua, New Hampshire, United States, 03062
United States, New Jersey
Associates In Dermatology Research
Rutherford, New Jersey, United States, 07070
Belleville Dermatology Ctr, PA
Belleville, New Jersey, United States, 07109
Hudson Dermatology and Skin Cancer Center
Hoboken, New Jersey, United States, 07030
Karen S. Harkaway, MD, LLC
Delran, New Jersey, United States, 08075
Linda Susan Marcus, MD, FAAD
Wyckoff, New Jersey, United States, 07481
Windsor Dermatology
East Windsor, New Jersey, United States, 08520
United States, New York
Arthritis Health Associates
Syracuse, New York, United States, 13210
Atlantic Dermatologic Associates, LLP
Lynbrook, New York, United States, 11563
Helendale Dermatology and Medical Spa
Rochester, New York, United States, 14609
Dermatology Associates
Staten Island, New York, United States, 10314
DermResearchCenter of New York, Inc
Stony Brook, New York, United States, 11790
DiGiovanna Family Care Center
North Massapequa, New York, United States, 11758
Buffalo Medical Group, PC
Williamsville, New York, United States, 14221
Jeffrey Schachne, MD
Jefferson Valley, New York, United States, 10535
Skin Search and Dermatology Associates of Rochester
Rochester, New York, United States, 14623
South Nassau Dermatology, P.C.
Oceanside, New York, United States, 11572
The Center for Dermatology at Lifetime Health
Rochester, New York, United States, 14623
The Dermatology Center
Bayside, New York, United States, 11360
Thomas O. McMeekin MD, PC
Rochester, New York, United States, 14623
United States, North Carolina
Wilmington Health Associates
Wilmington, North Carolina, United States, 28401
Atlantic Dermatology Associates PA
Wilmington, North Carolina, United States, 28401
Dermatology and Skin Cancer Center
Raleigh, North Carolina, United States, 27607
Duke University Medical Center
Durham, North Carolina, United States, 27710
Mid-Charlotte Dermatology and Research PLLC
Charlotte, North Carolina, United States, 28211
Andrus and Associates Dermatology, P.A.
Raleigh, North Carolina, United States, 27609
United States, Ohio
Wells Institute for Health Awareness
Kettering, Ohio, United States, 45429
DataPharm, Inc
Warren, Ohio, United States, 44483
DataPharm, Inc.
Canfield, Ohio, United States, 44406
Hudson Dermatology
Hudson, Ohio, United States, 44236
Jan Fu, MD and PhD
Mason, Ohio, United States, 45040
Judith Andreano MD, Inc.
Strongsville, Ohio, United States, 44136
Smith Clinic
Marion, Ohio, United States, 43302
The Cleveland Clinical Foundation
Cleveland, Ohio, United States, 44195
University Dermatology Consultants, Inc.
Cincinnati, Ohio, United States, 45242
University Hospitals Cleveland
Cleveland, Ohio, United States, 44106
Curtis W. Hawkins, MD
Akron, Ohio, United States, 44313
Wright State University
Dayton, Ohio, United States, 45408
United States, Oklahoma
Sooner Palmer Circle
Norman, Oklahoma, United States, 73069
United States, Oregon
Northwest Cutaneous Research Specialists
Portland, Oregon, United States, 97210
United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
Atlantic Skin and Cosmetic Surgery Group, PC
Malvern, Pennsylvania, United States, 19355
Dermatology Associates Of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States, 19462
East Penn. Dermatology
North Wales, Pennsylvania, United States, 19454
Jan K. Brydon, MD
Erie, Pennsylvania, United States, 16507
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, South Carolina
Advanced Dermatology and Laser Center
Greenville, South Carolina, United States, 29615
Dermatology and Laser Center of Charleston, PA
Charleston, South Carolina, United States, 29414
Dermatology Associates of the Low Country
Beaufort, South Carolina, United States, 29907
Dr. Marta Hampton
Charleston, South Carolina, United States, 29407
Germain Dermatology Associates
Mt Pleasant, South Carolina, United States, 29464
Southeastern Research Associates, Inc.
Taylors, South Carolina, United States, 29687
The Hillcrest Dermatology Center
Orangeburg, South Carolina, United States, 29118
United States, South Dakota
Dakota Dermatology, LTD
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Advanced Skin and Laser Center
Brentwood, Tennessee, United States, 37027
Murfreesboro Dermatology Clinic
Murfreesboro, Tennessee, United States, 37129
Dermatology Associates Of Knoxville
Knoxville, Tennessee, United States, 37917
Dermatology Research Associates Inc.
Nashville, Tennessee, United States, 37203
James E. Turner, MD, PhD, PC
Bartlett, Tennessee, United States, 38134
Dermatology Associates of Kingsport, PC
Kingsport, Tennessee, United States, 37660
Rivergate Dermatology
Goodlettsville, Tennessee, United States, 37072
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
The Skin Wellness Center, P.C.
Knoxville, Tennessee, United States, 37922
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2600
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246-1613
Dermatology Associates of San Antonio
San Antonio, Texas, United States, 78258
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229
Texas Familicare Clinical Research
Colleyville, Texas, United States, 76034
West Houston Dermatology, PA
Houston, Texas, United States, 77082
United States, Utah
Rocky Mountain Dermatology
Logan, Utah, United States, 84341
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Dermatology Associates, Inc.
Winchester, Virginia, United States, 22601
Education and Research Foundation
Lynchburg, Virginia, United States, 24501
Skin and Laser Surgery Center PC
Tysons Corner, Virginia, United States, 22182
Virginia Beach Dermatology Associates
Virginia Beach, Virginia, United States, 23464
Virginia Clinical Research
Norfolk, Virginia, United States, 23507
United States, Washington
Dermatology and Laser Center NW
Bellingham, Washington, United States, 98225
Dermatology Associates, PLLC
Seattle, Washington, United States, 98101
Eastern Washington Dermatology
Dayton, Washington, United States, 99328
Northwest Dermatology
Spokane, Washington, United States, 99218
Spokane Dermatology Clinic
Spokane, Washington, United States, 99204
United States, Wisconsin
Aylesworth Dermatology, SC
Rhinelander, Wisconsin, United States, 54501
Great Lakes Dermatology- Racine
Racine, Wisconsin, United States, 53406
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

Study placed in the following topic categories:
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

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

ClinicalTrials.gov processed this record on May 14, 2009