Clinical trial NCT00096928: A Study to Evaluate Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)
Official title: Raptiva Epidemiologic Study of Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Plaque Psoriasis
RESPONSE
Raptiva
efalizumab
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-18
Enrollment: 1846
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: managed care organizations, community or physician practices, and academic centers in the United States

Brief summary: 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center
state: Alabama
city: Daphne
country: United States
facility: Deep South Dermatology
state: Alabama
city: Gadsden
country: United States
facility: The Dermatology Center
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Huntsville
country: United States
facility: Ruth A. Yates, MD
state: Alabama
city: Glendale
country: United States
facility: SunValley Arthritis Center Ltd
state: Arizona
city: Phoenix
country: United States
facility: Alliance Dermatology and MOHS
state: Arizona
city: Little Rock
country: United States
facility: BGPDS Dermatology
state: Arkansas
city: Rogers
country: United States
facility: Hull Dermatology, PA
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Dermatology and Skin Cancer Medical Grp
state: California
city: Encino
country: United States
facility: T. Joseph Raoof, MD, Inc.
state: California
city: Fresno
country: United States
facility: Minarets Medical Group
state: California
city: Fresno
country: United States
facility: Associates In Research, Inc.
state: California
city: Inglewood
country: United States
facility: Delta Dermatology Medical Group
state: California
city: Lodi
country: United States
facility: Fairmont Dermatology Medical Associates, Inc
state: California
city: Los Angeles
country: United States
facility: Dermatology Associates
state: California
city: Mountain View
country: United States
facility: Elizabeth A. Abel, MD
state: California
city: Oxnard
country: United States
facility: Dermatology Medical Group of Oxnard
state: California
city: San Jose
country: United States
facility: Kent Carson, MD
state: California
city: San Ramon
country: United States
facility: East Bay Psoriasis Treatment Center
state: California
city: Santa Monica
country: United States
facility: Clinical Research Specialists, Inc.
state: California
city: Torrance
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Upland
country: United States
facility: Skin Physicians and Surgeons Medical Group, Inc.
state: California
city: Centennial
country: United States
facility: Centennial Cosmetic Surgery and Dermatology
state: Colorado
city: Denver
country: United States
facility: Colorado Medical Research Center, Inc.
state: Colorado
city: Englewood
country: United States
facility: Meridian Skin Cancer Center
state: Colorado
city: Greeley
country: United States
facility: Northern Colorado Allergy and Asthma Clinic
state: Colorado
city: Danbury
country: United States
facility: Dermatology Associates Of Western Connecticut
state: Connecticut
city: Washington
country: United States
facility: George Washington University Medical Center
state: District of Columbia
city: Aventura
country: United States
facility: Aventura Medical Research Inc
state: Florida
city: Aventura
country: United States
facility: Stephen N Horwitz, MD, PA
state: Florida
city: Boca Raton
country: United States
facility: Brent M Schillinger, MD, PA
state: Florida
city: Boca Raton
country: United States
facility: The Dermatology and Aesthetic Center
state: Florida
city: Boca Raton
country: United States
facility: David Hecker, MD
state: Florida
city: Coral Gables
country: United States
facility: Dermatology Associates and Research
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Jacksonville
country: United States
facility: Coastal Dermatology
state: Florida
city: Jupiter
country: United States
facility: Genesis Dermatology
state: Florida
city: Miami
country: United States
facility: University of Miami Dept. of Dermatology and Cutaneous Surgery
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Orlando
country: United States
facility: Central Florida Dermatology Associates, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: Dermatology Consultants of Broward
state: Florida
city: Pinellas Park
country: United States
facility: Dermatology Research by Dr. Gary L. Heller
state: Florida
city: Spring Hill
country: United States
facility: Clinical Research of Tampa Bay, Inc.
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein, and Research Center, LLC
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Carrollton
country: United States
facility: Dermatology Specialists of West Georgia
state: Georgia
city: Conyers
country: United States
facility: East Metro Dermatology
state: Georgia
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, Inc.
state: Georgia
city: Rome
country: United States
facility: Northwest Georgia Dermatology
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center Inc.
state: Georgia
city: Toccoa
country: United States
facility: Toccoa Clinic Medical Associates
state: Georgia
city: Honolulu
country: United States
facility: Queens Medical Center
state: Hawaii
city: Twin Falls
country: United States
facility: Alan Olmstead, MD
state: Idaho
city: Aurora
country: United States
facility: Fox Valley Dermatology LTD
state: Illinois
city: Champaign
country: United States
facility: Christie Clinic
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Danilo V. Del Campo
state: Illinois
city: Lincolnshire
country: United States
facility: Advanced Dermatology
state: Illinois
city: Mt Vernon
country: United States
facility: Skin Care Center Of Southern Illinois
state: Illinois
city: Schaumburg
country: United States
facility: Schaumburg Dermatology
state: Illinois
city: Crown Point
country: United States
facility: Dermatology Center of Northwest Indiana
state: Indiana
city: Ft. Wayne
country: United States
facility: Three Rivers Dermatology
state: Indiana
city: Indianapolis
country: United States
facility: Dermatology Associates, PC
state: Indiana
city: Indianapolis
country: United States
facility: Investigators Research Group
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: The Dermatology Center PSC
state: Indiana
city: Plainfield
country: United States
facility: The Dermatology Center of Indiana
state: Indiana
city: West Lafayette
country: United States
facility: Randall Dermatology, PC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Dermatology, PA
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic
state: Kansas
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Louisville
country: United States
facility: Derm Research, PLLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Louisiana Dermatology Associates
state: Louisiana
city: Lake Charles
country: United States
facility: Dermatology and Advanced Aesthetics
state: Louisiana
city: Shreveport
country: United States
facility: Highland Clinic, APMC
state: Louisiana
city: Bethesda
country: United States
facility: Washington Dermatology Center
state: Maryland
city: Mitchellville
country: United States
facility: Callender Skin and Laser Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Womens' Hospital
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Skin Care Physicians of Chestnut Hill
state: Massachusetts
city: Norwood
country: United States
facility: Dermatology Associates
state: Massachusetts
city: Worcester
country: United States
facility: Worcester Dermatology
state: Massachusetts
city: Ann Arbor
country: United States
facility: David Fivenson, MD Dermatology, PLLC
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Grand Rapids
country: United States
facility: Psoriasis and Eczema Treatment Center of Western Michigan PLLC
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Waterford
country: United States
facility: M. Siegel, MD PC
state: Michigan
city: Kirksville
country: United States
facility: Lloyd J. Cleaver, DO, LLC
state: Missouri
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: St. Louis
country: United States
facility: Central Dermatology, PC
state: Missouri
city: St. Louis
country: United States
facility: Jacquelyn B. Garrett
state: Missouri
city: St. Louis
country: United States
facility: Karen E Forsman, MD Dermatology LLC
state: Missouri
city: Lincoln
country: United States
facility: South Lincoln Dermatology
state: Nebraska
city: Las Vegas
country: United States
facility: Woodson Dermatology
state: Nevada
city: Reno
country: United States
facility: Nevada Center For Dermatology, Ltd
state: Nevada
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Nashua
country: United States
facility: Nashua Dermatology Associates
state: New Hampshire
city: Nashua
country: United States
facility: Nashua Dermatology
state: New Hampshire
city: Belleville
country: United States
facility: Belleville Dermatology Ctr, PA
state: New Jersey
city: Delran
country: United States
facility: Karen S. Harkaway, MD, LLC
state: New Jersey
city: East Windsor
country: United States
facility: Windsor Dermatology
state: New Jersey
city: Hoboken
country: United States
facility: Hudson Dermatology and Skin Cancer Center
state: New Jersey
city: Rutherford
country: United States
facility: Associates In Dermatology Research
state: New Jersey
city: Wyckoff
country: United States
facility: Linda Susan Marcus, MD, FAAD
state: New Jersey
city: Bayside
country: United States
facility: The Dermatology Center
state: New York
city: Jefferson Valley
country: United States
facility: Jeffrey Schachne, MD
state: New York
city: Lynbrook
country: United States
facility: Atlantic Dermatologic Associates, LLP
state: New York
city: North Massapequa
country: United States
facility: DiGiovanna Family Care Center
state: New York
city: Oceanside
country: United States
facility: South Nassau Dermatology, P.C.
state: New York
city: Rochester
country: United States
facility: Helendale Dermatology and Medical Spa
state: New York
city: Rochester
country: United States
facility: Skin Search and Dermatology Associates of Rochester
state: New York
city: Rochester
country: United States
facility: The Center for Dermatology at Lifetime Health
state: New York
city: Rochester
country: United States
facility: Thomas O. McMeekin MD, PC
state: New York
city: Staten Island
country: United States
facility: Dermatology Associates
state: New York
city: Stony Brook
country: United States
facility: DermResearchCenter of New York, Inc
state: New York
city: Syracuse
country: United States
facility: Arthritis Health Associates
state: New York
city: Williamsville
country: United States
facility: Buffalo Medical Group, PC
state: New York
city: Charlotte
country: United States
facility: Mid-Charlotte Dermatology and Research PLLC
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Dermatology and Skin Cancer Center
state: North Carolina
city: Raleigh
country: United States
facility: Andrus and Associates Dermatology, P.A.
state: North Carolina
city: Wilmington
country: United States
facility: Atlantic Dermatology Associates PA
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health Associates
state: North Carolina
city: Akron
country: United States
facility: Curtis W. Hawkins, MD
state: Ohio
city: Canfield
country: United States
facility: DataPharm, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: University Dermatology Consultants, Inc.
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinical Foundation
state: Ohio
city: Dayton
country: United States
facility: Wright State University
state: Ohio
city: Hudson
country: United States
facility: Hudson Dermatology
state: Ohio
city: Kettering
country: United States
facility: Wells Institute for Health Awareness
state: Ohio
city: Marion
country: United States
facility: Smith Clinic
state: Ohio
city: Mason
country: United States
facility: Jan Fu, MD and PhD
state: Ohio
city: Strongsville
country: United States
facility: Judith Andreano MD, Inc.
state: Ohio
city: Warren
country: United States
facility: DataPharm, Inc
state: Ohio
city: Norman
country: United States
facility: Sooner Palmer Circle
state: Oklahoma
city: Portland
country: United States
facility: Northwest Cutaneous Research Specialists
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Erie
country: United States
facility: Jan K. Brydon, MD
state: Pennsylvania
city: Malvern
country: United States
facility: Atlantic Skin and Cosmetic Surgery Group, PC
state: Pennsylvania
city: North Wales
country: United States
facility: East Penn. Dermatology
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Dermatology Associates Of Plymouth Meeting
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Beaufort
country: United States
facility: Dermatology Associates of the Low Country
state: South Carolina
city: Charleston
country: United States
facility: Dr. Marta Hampton
state: South Carolina
city: Charleston
country: United States
facility: Dermatology and Laser Center of Charleston, PA
state: South Carolina
city: Greenville
country: United States
facility: Advanced Dermatology and Laser Center
state: South Carolina
city: Mt Pleasant
country: United States
facility: Germain Dermatology Associates
state: South Carolina
city: Orangeburg
country: United States
facility: The Hillcrest Dermatology Center
state: South Carolina
city: Taylors
country: United States
facility: Southeastern Research Associates, Inc.
state: South Carolina
city: Sioux Falls
country: United States
facility: Dakota Dermatology, LTD
state: South Dakota
city: Bartlett
country: United States
facility: James E. Turner, MD, PhD, PC
state: Tennessee
city: Brentwood
country: United States
facility: Advanced Skin and Laser Center
state: Tennessee
city: Goodlettsville
country: United States
facility: Rivergate Dermatology
state: Tennessee
city: Kingsport
country: United States
facility: Dermatology Associates of Kingsport, PC
state: Tennessee
city: Knoxville
country: United States
facility: Dermatology Associates Of Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: The Skin Wellness Center, P.C.
state: Tennessee
city: Murfreesboro
country: United States
facility: Murfreesboro Dermatology Clinic
state: Tennessee
city: Nashville
country: United States
facility: Dermatology Research Associates Inc.
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Colleyville
country: United States
facility: Texas Familicare Clinical Research
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: West Houston Dermatology, PA
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Dermatology Associates of San Antonio
state: Texas
city: Logan
country: United States
facility: Rocky Mountain Dermatology
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Lynchburg
country: United States
facility: Education and Research Foundation
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Tysons Corner
country: United States
facility: Skin and Laser Surgery Center PC
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Beach Dermatology Associates
state: Virginia
city: Winchester
country: United States
facility: Dermatology Associates, Inc.
state: Virginia
city: Bellingham
country: United States
facility: Dermatology and Laser Center NW
state: Washington
city: Dayton
country: United States
facility: Eastern Washington Dermatology
state: Washington
city: Seattle
country: United States
facility: Dermatology Associates, PLLC
state: Washington
city: Spokane
country: United States
facility: Spokane Dermatology Clinic
state: Washington
city: Spokane
country: United States
facility: Northwest Dermatology
state: Washington
city: Racine
country: United States
facility: Great Lakes Dermatology- Racine
state: Wisconsin
city: Rhinelander
country: United States
facility: Aylesworth Dermatology, SC
state: Wisconsin
Study officials:
affiliation: Genentech, Inc.
name: Ivor Caro, M.D.
role: STUDY_DIRECTOR
References: