PsoriasisRESPONSENCT00096928
A Study to Evaluate Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)
An observational study of Psoriasis, run by Genentech, Inc. at 182 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- How many people
- 1,846 participants
- Where
- 182 sitesUnited States
- Study dates
- Mar 2005to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: managed care organizations, community or physician practices, and academic centers in the United States
Who may be able to join
- 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)
Who cannot join
- Have previously received at least one dose of Raptiva and are not currently using or restarting treatment with Raptiva at the time of enrollment
Trial locations and contacts
182 sites in 1 country.
182 sites in 1 country
United States182 sites
Curtis W. Hawkins, MD
Akron, Ohio, 44313
Atlanta Dermatology, Vein, and Research Center, LLC
Alpharetta, Georgia, 30005
David Fivenson, MD Dermatology, PLLC
Ann Arbor, Michigan, 48103
Emory University
Atlanta, Georgia, 30322
Fox Valley Dermatology LTD
Aurora, Illinois, 60502
Aventura Medical Research Inc
Aventura, Florida, 33180
Stephen N Horwitz, MD, PA
Aventura, Florida, 33180
Bakersfield Dermatology and Skin Cancer Medical Grp
Bakersfield, California, 93309
James E. Turner, MD, PhD, PC
Bartlett, Tennessee, 38134
Louisiana Dermatology Associates
Baton Rouge, Louisiana, 70806
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
The Dermatology Center
Bayside, New York, 11360
Dermatology Associates of the Low Country
Beaufort, South Carolina, 29907
Belleville Dermatology Ctr, PA
Belleville, New Jersey, 07109
Dermatology and Laser Center NW
Bellingham, Washington, 98225
Washington Dermatology Center
Bethesda, Maryland, 20814
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35205
Brent M Schillinger, MD, PA
Boca Raton, Florida, 33433
The Dermatology and Aesthetic Center
Boca Raton, Florida, 33486
David Hecker, MD
Boca Raton, Florida, 33496
Brigham and Womens' Hospital
Boston, Massachusetts, 02115
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
Advanced Skin and Laser Center
Brentwood, Tennessee, 37027
Fletcher Allen Health Care
Burlington, Vermont, 05401
DataPharm, Inc.
Canfield, Ohio, 44406
Dermatology Specialists of West Georgia
Carrollton, Georgia, 30117
Centennial Cosmetic Surgery and Dermatology
Centennial, Colorado, 80112
Christie Clinic
Champaign, Illinois, 61820
Dr. Marta Hampton
Charleston, South Carolina, 29407
Dermatology and Laser Center of Charleston, PA
Charleston, South Carolina, 29414
Mid-Charlotte Dermatology and Research PLLC
Charlotte, North Carolina, 28211
Skin Care Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, 02467
Northwestern University
Chicago, Illinois, 60611
Danilo V. Del Campo
Chicago, Illinois, 60641
University Dermatology Consultants, Inc.
Cincinnati, Ohio, 45242
University Hospitals Cleveland
Cleveland, Ohio, 44106
The Cleveland Clinical Foundation
Cleveland, Ohio, 44195
Texas Familicare Clinical Research
Colleyville, Texas, 76034
East Metro Dermatology
Conyers, Georgia, 30012
Dermatology Associates and Research
Coral Gables, Florida, 33134
Dermatology Center of Northwest Indiana
Crown Point, Indiana, 46307
Baylor Research Institute
Dallas, Texas, 75246-1613
Dermatology Associates Of Western Connecticut
Danbury, Connecticut, 06810
Deep South Dermatology
Daphne, Alabama, 36526
Wright State University
Dayton, Ohio, 45408
Eastern Washington Dermatology
Dayton, Washington, 99328
Colorado Medical Research Center, Inc.
Denver, Colorado, 80210
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Duke University Medical Center
Durham, North Carolina, 27710
Windsor Dermatology
East Windsor, New Jersey, 08520
T. Joseph Raoof, MD, Inc.
Encino, California, 91436
Meridian Skin Cancer Center
Englewood, Colorado, 80112
Jan K. Brydon, MD
Erie, Pennsylvania, 16507
Three Rivers Dermatology
Fort Wayne, Indiana, 46804
Minarets Medical Group
Fresno, California, 93711
Associates In Research, Inc.
Fresno, California, 93720
The Dermatology Center
Gadsden, Alabama, 35901
SunValley Arthritis Center Ltd
Glendale, Arizona, 85308-7100
Rivergate Dermatology
Goodlettsville, Tennessee, 37072
Psoriasis and Eczema Treatment Center of Western Michigan PLLC
Grand Rapids, Michigan, 49503
Northern Colorado Allergy and Asthma Clinic
Greeley, Colorado, 80634
Advanced Dermatology and Laser Center
Greenville, South Carolina, 29615
Hudson Dermatology and Skin Cancer Center
Hoboken, New Jersey, 07030
Queens Medical Center
Honolulu, Hawaii, 96813
West Houston Dermatology, PA
Houston, Texas, 77082
Hudson Dermatology
Hudson, Ohio, 44236
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
Ruth A. Yates, MD
Huntsville, Alabama, 35801
Dermatology Associates, PC
Indianapolis, Indiana, 46240
Investigators Research Group
Indianapolis, Indiana, 46254
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Delta Dermatology Medical Group
Inglewood, California, 90301
University of Iowa Health Care
Iowa City, Iowa, 52242
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204
Coastal Dermatology
Jacksonville, Florida, 32246
Jeffrey Schachne, MD
Jefferson Valley, New York, 10535
Clinical Partners, LLC
Johnston, Rhode Island, 02919
Genesis Dermatology
Jupiter, Florida, 33458
Wells Institute for Health Awareness
Kettering, Ohio, 45429
Dermatology Associates of Kingsport, PC
Kingsport, Tennessee, 37660
Lloyd J. Cleaver, DO, LLC
Kirksville, Missouri, 63501
Dermatology Associates Of Knoxville
Knoxville, Tennessee, 37917
The Skin Wellness Center, P.C.
Knoxville, Tennessee, 37922
Dermatology and Advanced Aesthetics
Lake Charles, Louisiana, 70601
Woodson Dermatology
Las Vegas, Nevada, 89128
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
South Lincoln Dermatology
Lincoln, Nebraska, 68502
Advanced Dermatology
Lincolnshire, Illinois, 60069
BGPDS Dermatology
Little Rock, Arkansas, 72205
Fairmont Dermatology Medical Associates, Inc
Lodi, California, 95242
Rocky Mountain Dermatology
Logan, Utah, 84341
Dermatology Associates
Los Angeles, California, 90045
Derm Research, PLLC
Louisville, Kentucky, 40217
Atlantic Dermatologic Associates, LLP
Lynbrook, New York, 11563
Education and Research Foundation
Lynchburg, Virginia, 24501
Dermatologic Surgery Specialists, Inc.
Macon, Georgia, 31217
Atlantic Skin and Cosmetic Surgery Group, PC
Malvern, Pennsylvania, 19355
Smith Clinic
Marion, Ohio, 43302
Jan Fu, MD and PhD
Mason, Ohio, 45040
University of Miami Dept. of Dermatology and Cutaneous Surgery
Miami, Florida, 33136
Callender Skin and Laser Center
Mitchellville, Maryland, 20721
Skin Care Center Of Southern Illinois
Mount Vernon, Illinois, 62864
Elizabeth A. Abel, MD
Mountain View, California, 94040
Germain Dermatology Associates
Mt. Pleasant, South Carolina, 29464
Murfreesboro Dermatology Clinic
Murfreesboro, Tennessee, 37129
Nashua Dermatology Associates
Nashua, New Hampshire, 03062
Nashua Dermatology
Nashua, New Hampshire, 03062
Dermatology Research Associates Inc.
Nashville, Tennessee, 37203
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2600
The Dermatology Center PSC
New Albany, Indiana, 47150
Virginia Clinical Research
Norfolk, Virginia, 23507
Sooner Palmer Circle
Norman, Oklahoma, 73069
DiGiovanna Family Care Center
North Massapequa, New York, 11758
East Penn. Dermatology
North Wales, Pennsylvania, 19454
Dermatology Associates
Norwood, Massachusetts, 02062
South Nassau Dermatology, P.C.
Oceanside, New York, 11572
Park Avenue Dermatology
Orange Park, Florida, 32073
The Hillcrest Dermatology Center
Orangeburg, South Carolina, 29118
Central Florida Dermatology Associates, Inc.
Orlando, Florida, 32806
Kansas City Dermatology, PA
Overland Park, Kansas, 66215
Dermatology Medical Group of Oxnard
Oxnard, California, 93030
Dermatology Consultants of Broward
Pembroke Pines, Florida, 33028
Alliance Dermatology and MOHS
Phoenix, Arizona, 85032
Dermatology Research by Dr. Gary L. Heller
Pinellas Park, Florida, 33781
The Dermatology Center of Indiana
Plainfield, Indiana, 46168
Dermatology Associates Of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
Northwest Cutaneous Research Specialists
Portland, Oregon, 97210
Great Lakes Dermatology- Racine
Racine, Wisconsin, 53406
Dermatology and Skin Cancer Center
Raleigh, North Carolina, 27607
Andrus and Associates Dermatology, P.A.
Raleigh, North Carolina, 27609
Nevada Center For Dermatology, Ltd
Reno, Nevada, 89511
Skin Cancer and Dermatology Institute
Reno, Nevada, 89511
Aylesworth Dermatology, SC
Rhinelander, Wisconsin, 54501
Karen S. Harkaway, MD, LLC
Riverside Park, New Jersey, 08075
Helendale Dermatology and Medical Spa
Rochester, New York, 14609
Skin Search and Dermatology Associates of Rochester
Rochester, New York, 14623
The Center for Dermatology at Lifetime Health
Rochester, New York, 14623
Thomas O. McMeekin MD, PC
Rochester, New York, 14623
Hull Dermatology, PA
Rogers, Arkansas, 72758
Northwest Georgia Dermatology
Rome, Georgia, 30165
Associates In Dermatology Research
Rutherford, New Jersey, 07070
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Dermatology Associates of San Antonio
San Antonio, Texas, 78258
Kent Carson, MD
San Jose, California, 95123
East Bay Psoriasis Treatment Center
San Ramon, California, 94583
Clinical Research Specialists, Inc.
Santa Monica, California, 90404
Schaumburg Dermatology
Schaumburg, Illinois, 60194
Dermatology Associates, PLLC
Seattle, Washington, 98101
Highland Clinic, APMC
Shreveport, Louisiana, 71105
Dakota Dermatology, LTD
Sioux Falls, South Dakota, 57108
Gwinnett Clinical Research Center Inc.
Snellville, Georgia, 30078
Spokane Dermatology Clinic
Spokane, Washington, 99204
Northwest Dermatology
Spokane, Washington, 99218
Clinical Research of Tampa Bay, Inc.
Spring Hill, Florida, 34609
Saint Louis University
St Louis, Missouri, 63104
Central Dermatology, PC
St Louis, Missouri, 63117
Jacquelyn B. Garrett
St Louis, Missouri, 63136
Karen E Forsman, MD Dermatology LLC
St Louis, Missouri, 63141
Dermatology Associates
Staten Island, New York, 10314
DermResearchCenter of New York, Inc
Stony Brook, New York, 11790
Judith Andreano MD, Inc.
Strongsville, Ohio, 44136
Arthritis Health Associates
Syracuse, New York, 13210
Southeastern Research Associates, Inc.
Taylors, South Carolina, 29687
Toccoa Clinic Medical Associates
Toccoa, Georgia, 30577
Kansas Medical Clinic
Topeka, Kansas, 66614
Healthcare Partners Medical Group
Torrance, California, 90503
Somerset Skin Centre
Troy, Michigan, 48084
Alan Olmstead, MD
Twin Falls, Idaho, 83301
Skin and Laser Surgery Center PC
Tysons Corner, Virginia, 22182
Skin Physicians and Surgeons Medical Group, Inc.
Upland, California, 91786
Virginia Beach Dermatology Associates
Virginia Beach, Virginia, 23464
DataPharm, Inc
Warren, Ohio, 44483
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
M. Siegel, MD PC
Waterford, Michigan, 48328-3735
Randall Dermatology, PC
West Lafayette, Indiana, 47906
Buffalo Medical Group, PC
Williamsville, New York, 14221
Atlantic Dermatology Associates PA
Wilmington, North Carolina, 28401
Wilmington Health Associates
Wilmington, North Carolina, 28401
Dermatology Associates, Inc.
Winchester, Virginia, 22601
Worcester Dermatology
Worcester, Massachusetts, 01608
Linda Susan Marcus, MD, FAAD
Wyckoff, New Jersey, 07481
About this study
Official title: Raptiva Epidemiologic Study of Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)
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.
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, RESPONSE, Raptiva, efalizumab
- Medical subject headings
- Psoriasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2004 (estimated)
- Study startMar 2005
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ivor Caro, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096928
- Sponsor's protocol ID
- ACD3101g
- Acronym
- RESPONSE
- Status last verified
- Mar 2011
- First submitted
- 17 Nov 2004
- Last updated
- 2 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raptiva Epidemiologic Study of Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)
- ClinicalTrials.gov ID
- NCT00096928
- Acronym / sponsor ID
- RESPONSE / ACD3101g
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, RESPONSE, Raptiva, efalizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,846 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Oct 2009 (actual)
- First posted
- 18 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- managed care organizations, community or physician practices, and academic centers in the United States
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Have previously received at least one dose of Raptiva and are not currently using or restarting treatment with Raptiva at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivor Caro, M.D. study director
Genentech, Inc.
182 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Genentech, Inc. at 182 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 182 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2015.