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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00454701
Other study ID # 0485-CL-0001
Secondary ID C-736
Status Terminated
Phase Phase 4
First received March 29, 2007
Last updated December 10, 2013
Start date June 2003
Est. completion date February 2012

Study information

Verified date December 2013
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardCanada: Health Canada
Study type Observational

Clinical Trial Summary

Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months to gather general health information.


Description:

There are no study-mandated tests, visits or clinical interventions after the 1st (enrolling) visit. After the patient is enrolled in the study, they will be contacted every 6 months to complete structured telephone interviews conducted by the ATLAS Study Center.


Recruitment information / eligibility

Status Terminated
Enrollment 1897
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Psoriasis patients who are prescribed alefacept consistent with product labeling are eligible for enrollment.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Alefacept exposure
Observational

Locations

Country Name City State
Canada Clinique de dermatologie Dr. Francois Bouchard Alma Quebec
Canada Francoise Giard Gatineau Quebec
Canada Dermatrials Research Hamilton Ontario
Canada Limestone Dermatology & Laser Clinic Kingston Ontario
Canada Mediprobe Research, Inc. London Ontario
Canada The Guenther Dermatology Research Centre London Ontario
Canada Wellington Dermatology Associates London Ontario
Canada Lynderm Research, Inc. Markham Ontario
Canada Innovaderm Research, Inc Montreal Quebec
Canada Siena Medical Research Montreal Quebec
Canada A.M. Katz Medicine D.C. Newmarket Ontario
Canada John J. Turner, MD Newmarket Ontario
Canada Dermatology Clinic North York Ontario
Canada Skin Centre for Dermatology Peterborough Ontario
Canada Giles P. Raymond Pierrefonds Quebec
Canada CRCMR Gilbert Inc. Quebec
Canada (CRDQ) Centre De Recherche Dermatologique Du Quebec Metropolitan Quebec City Quebec
Canada Douglas N. Keeling MD Dermatologist PC Quispamsis New Brunswick
Canada Victoria East Medical Clinic Regina Saskatchewan
Canada NewLab Clinical Research, Inc. St. John's Newfoundland and Labrador
Canada Nexus Clinical Research St. John's Newfoundland and Labrador
Canada Sudbury Skin Clinic Sudbury Ontario
Canada Dermatology Associates Toronto Ontario
Canada Specialized Dermatology Welland Ontario
Canada Winnipeg Clinic Winnepeg Manitoba
Canada Dermadvances Research Winnipeg Manitoba
United States Davie Dermatology Advance North Carolina
United States Paul S. Takiguchi- MD- Inc. Aiea Hawaii
United States Derm & Skin Cancer Surgery Center Allen Texas
United States Jerri L. Johnson MD, PA Altamonte Springs Florida
United States Arlington Center for Dermatology Arlington Texas
United States Altman Dermatology Associates Arlington Heights Illinois
United States Skyland Dermatology and Psychiatry Asheville North Carolina
United States William S. Mirando, MD, LLC Ashtabula Ohio
United States Darren Casey Atlanta Georgia
United States Emory University School of Medicine Atlanta Georgia
United States Family Dermatology-Cynthia A. Abbott, MD Atlanta Georgia
United States Georgia Skin Specialists Atlanta Georgia
United States Peachtree Dermatology Associates Atlanta Georgia
United States Midsouth Dermatology and Skin Cancer Center Bartlett Tennessee
United States LA Dermatology Assoc LLC Baton Rouge Louisiana
United States Dermatology Associates of the Low Counties Beaufort South Carolina
United States Robert M. Stiegel- M.D. LTD Beaver Pennsylvania
United States Benjamin Bernstein Bel Air Maryland
United States Bellaire Dermatology Associates Bellaire Texas
United States Dermatology & Laser Center Northwest Bellingham Washington
United States Lehigh Valley Dermatology Bethlehem Pennsylvania
United States Northeast Dermatology Beverly Massachusetts
United States Janet Cash Birmingham Alabama
United States Total Skin and Beauty Dermatology Center Birmingham Alabama
United States Advanced Dermatology Associates, PC Bloomington Indiana
United States Thomas Brander Bloomington Illinois
United States Center for Dermatology Boca Raton Florida
United States Jodi Fiedler Boca Raton Florida
United States Brigham and Women's Hospital Boston Massachusetts
United States Advanced Skin & Laser Center Brentwood Tennessee
United States Jeremy Moss, MD Bridgeport Connecticut
United States Susan E. Katz MD Bronx New York
United States Buffalo Medical Group Buffalo New York
United States Jeffrey N Samuelson Burnsville Minnesota
United States Calumet Dermatology Associates S.C. Calumet City Illinois
United States Dermatology and Skin Surgery Center, PA Celebration Florida
United States Advanced Dermatology Centennial Colorado
United States Eugene Conte Centerville Ohio
United States Christie Clinic Champaign Illinois
United States Marta Hampton Charleston South Carolina
United States Rheumatology Associates Charleston South Carolina
United States Curtis W. Schupbach- MD Charlotte North Carolina
United States The Dermatology Group LLC Chevy Chase Maryland
United States Cheyenne Dermatology- P.C. Cheyenne Wyoming
United States Danilo Del Campo Chicago Illinois
United States University Dermatology Consultants, Inc. Cincinnati Ohio
United States Wendy McFalda, DO Clarkston Michigan
United States Drs. Iacobelli & DiGregorio, PC Clinton Township Michigan
United States McClerklin Skin and Laser Center Columbia South Carolina
United States The Dermatology Group, LLC Columbia South Carolina
United States Allen B. Filstein, MD Conyers Georgia
United States East Metro Dermatology, PC Conyers Georgia
United States Melissa Knuckles Corbin Kentucky
United States Alpha Therapy Center Corpus Christi Texas
United States Spencer Dermatology Associates LLC Crawfordsville Indiana
United States Mitchell Bressack Crown Point Indiana
United States Raymond Blackburn Dallas Texas
United States Martha Hickmann, MD Dayton Ohio
United States Brent M Schillinger Delray Beach Florida
United States Dermatology & Laser Center at Harvard Park, PLLC Denver Colorado
United States North Atlanta Dermatology Duluth Georgia
United States Psoriasis Treatment Center of Central NJ East Windsor New Jersey
United States Advancements In Derm Edina Minnesota
United States Michael A. Greenberg, MD, Ltd. Elk Grove Village Illinois
United States Dermatology & Advanced Skin Care Ellicott City Maryland
United States Joyce Lender Elyria Ohio
United States Jan Brydon Erie Pennsylvania
United States Bay Shore Dermatology & Laser Surgery Center Fairhope Alabama
United States Ozark Dermatology Clinic Fayetteville Arkansas
United States Bruce Goldstein Florence Massachusetts
United States Bruce S. Stein Flushing New York
United States Cyril E Severns Fort Smith Arkansas
United States Fort Wayne Dermatology Fort Wayne Indiana
United States Betty J. Rajan Fort Worth Texas
United States East Bay Dermatology Medical Group Inc. DBA Center for Dermatology, Cosmetic & Laser Surgery, Inc Fremont California
United States East Bay Dermatology Medical Group Inc., DBA Center for Dermatology, Cosmetic and Laser Surgery Fremont California
United States Advanced Dermatology Fresh Meadows New York
United States Minarets Medical Group, Inc. Fresno California
United States Jack C. Scott Fridley Minnesota
United States Steven E. Prawer Fridley Minnesota
United States Eric Baum Gadsden Alabama
United States Northeast Dermatology & Cosmetic Surgery Gahanna Ohio
United States Frank De Mento Garden City New York
United States Garden City Dermatology, P.C. Garden City New York
United States Lisa Garner Garland Texas
United States John J. Guagenti, MD Glendale California
United States Rivergate Dermatology Research Center Goodlettsville Tennessee
United States D.B.A. Colorado West Dermatology Grand Junction Colorado
United States Psoriasis and Eczema Treatment Center of Western Michigan Grand Rapids Michigan
United States Layton Avenue Dermatology Greenfield Wisconsin
United States John Humeniuk Greenville South Carolina
United States Dimitri Dermatology Gretna Louisiana
United States Eric R. Wolf, MD Groton Connecticut
United States The Dermatology Clinic- PLLC Gulfport Mississippi
United States North Suburban Dermatology Associates Gurnee Illinois
United States David Amato Harrisburg Pennsylvania
United States Saye & Gette Dermatology Associates, PC Harrisburg Pennsylvania
United States Mark Gallardo Hattiesburg Mississippi
United States Great Plains Dermatology- P.A. Hays Kansas
United States Associated Dermatology Helena Montana
United States Chad Mathews Hermitage Pennsylvania
United States A.G.A. Clinical Trials Hialeah Florida
United States Burke Pharmaceutical Research Hot Springs Arkansas
United States Lone Star Children's Medical PLLC Houston Texas
United States West Houston Dermatology, PA Houston Texas
United States Edmund Lee Huntington New York
United States Ruth A Yates Huntsville Alabama
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States Tsu-Yi Chuang Indianapolis Indiana
United States Dermatology and Laser Center Irving Texas
United States Coastal Dermatology, PA Jacksonville Florida
United States North Florida Dermatology Associates, P.A. Jacksonville Florida
United States Jeffrey P Schachne Jefferson Valley New York
United States Clinical Partners, LLC Johnston Rhode Island
United States A Center for Dermatology, Cosmetic and Laser Surgery Jupiter Florida
United States Andrew Berg Kansas City Missouri
United States Dermatology Associates of Kingsport, PC Kingsport Tennessee
United States Steven J. Smith, MD Kingwood Texas
United States Dermatology Associates of Knoxville, PC Knoxville Tennessee
United States Scripps Clinic La Mesa California
United States Dermatology Associates of LaGrange LaGrange Highlands Illinois
United States Allergy, Asthma & Dermatology Research Centers, LLC Lake Oswego Oregon
United States Dermatology Associates of Lancaster Lancaster Pennsylvania
United States Stephanie Mackey Lancaster Pennsylvania
United States Johnnie M Woodson Las Vegas Nevada
United States Robert B. Stromling, MD Las Vegas Nevada
United States Little Rock Dermatology Clinic Little Rock Arkansas
United States Livonia Dermatology, PLLC Livonia Michigan
United States Fairmont Dermatology Lodi California
United States Rocky Mountain Dermatology Logan Utah
United States Mark S Wallis Longview Texas
United States Lubbock Dermatology and Skin Cancer Center Lubbock Texas
United States Dermatology of East Texas Lufkin Texas
United States Atlantic Dermatologic Associates, LLC Lynbrook New York
United States Dermatologic Surgery Specialist Inc. Macon Georgia
United States Mark Lewis Marblehead Massachusetts
United States Delta Medical Ctr. Memphis Tennessee
United States Mobile Dermatology Mobile Alabama
United States Orange Dermatology Assoc, PC Monroe New York
United States Allegheny Dermatology Assoc., PC Monroeville Pennsylvania
United States Lesly S. Davidson MD PA Mount Pleasant South Carolina
United States California Skin Institute Mountain View California
United States Grand Strand Dermatology, LLC Myrtle Beach South Carolina
United States Saltzer Medical Group, PA Nampa Idaho
United States Associates in Medical and Surgical Dermatology Naples Florida
United States Nashua Dermatology Associates Nashua New Hampshire
United States Abigail James, NP, MSN Nashville Tennessee
United States Tennessee Clinical Research Center Nashville Tennessee
United States Jay A. Goldstein, MD Natick Massachusetts
United States Peter S. Halperin's Office New York New York
United States Panzer Dermatology Assoc. Newark Delaware
United States East Penn Dermatology North Wales Pennsylvania
United States Bender and Kolenik MD, PC Norwalk Connecticut
United States Charles Halasz Norwalk Connecticut
United States Stuart Bender Norwalk Connecticut
United States Dermatology & Laser Center Orange Park Florida
United States Hillcrest Dermatology Center, PA Orangeburg South Carolina
United States Peter Accetta Orchard Park New York
United States Aspen Clinical Research, LLC Orem Utah
United States Advanced Dermatology Orlando Florida
United States John L. Meisenheimer, MD Orlando Florida
United States Reflections Dermatology & Center for Skin Care Orlando Florida
United States Ormond Beach Dermatology Ormond Beach Florida
United States Waters Edge Dermatology Palm Beach Gardens Florida
United States Mark Cheiken Palm Coast Florida
United States Timothy Kelly, MD, PA Palm Harbor Florida
United States Ashkan Ghorbani Pasadena Texas
United States Paul T. Zaydon MD Pawtucket Rhode Island
United States Snyder & Le M.D. PA Pembroke Pines Florida
United States Kevin L Welch Pensacola Florida
United States Soderstrom Dermatology Center Peoria Illinois
United States David Coynik Peru Illinois
United States Paddington Testing Co, Inc. Philadelphia Pennsylvania
United States English Dermatology Centers Phoenix Arizona
United States Louis H. Martone, MD, PC Pittsburgh Pennsylvania
United States Neil M. Niren MD Pittsburgh Pennsylvania
United States Dermatology Associates of Plymouth Meeting- P.C. Plymouth Meeting Pennsylvania
United States Hecker Dermatology Group PA Pompano Beach Florida
United States Kenneth M. Reed, MD Quincy Massachusetts
United States Andrus & Associates Dermatology, PA Raleigh North Carolina
United States Aylesworth Dermatology SC Rhinelander Wisconsin
United States Georgia A Seely Richmond Virginia
United States North Bergen Dermatologic Group Ridgewood New Jersey
United States Dermatology Partners of Western New York Rochester New York
United States Greater Washington Dermatology P.A. Rockville Maryland
United States Todd Colonna Rockville Maryland
United States Gregory W Thompson San Antonio Texas
United States Clinical Research Specialists, Inc. Santa Monica California
United States Schaumburg Dermatology Schaumburg Illinois
United States Scottsdale Dermatology Scottsdale Arizona
United States Dermatology Associates, PLLC Seattle Washington
United States James Hu MD PC Seattle Washington
United States Joseph Bikowski Sewickley Pennsylvania
United States American Dermatology Associates Shawnee Kansas
United States Alan E. Lasser MD PC Skokie Illinois
United States Dermatique Dermedy Dermatology- PC Smithtown New York
United States Marina I Peredo, MD Smithtown New York
United States Four Seasons Dermatology South Burlington Vermont
United States DeVore Dermatology, PA Spartanburg South Carolina
United States Eric Olson Springfield Oregon
United States Ronald S. Nadel Springfield Massachusetts
United States Sharon K Tiefenbrunn St Louis Missouri
United States Josiane Lederman, MD, PC Staten Island New York
United States Judith Andreano Strongsville Ohio
United States Joseph D. Sutton, MD Suffern New York
United States Harvey L. Handler, MD Sylvania Ohio
United States James M. Komorous MD PS Tacoma Washington
United States Luis T. Menendez, MD, PA Tampa Florida
United States Michael A. Scannon MD, PA Tampa Florida
United States Medical College of Ohio Toledo Ohio
United States Kansas Medical Clinic, PA Topeka Kansas
United States Somerset Skin Centre Troy Michigan
United States Paul Klas Tualatin Oregon
United States Sheftel & Associates Dermatology Tucson Arizona
United States Options Health Research Tulsa Oklahoma
United States Dermatology Research Associates of Tyler Tyler Texas
United States Timothy Abrahamson Urbandale Iowa
United States Martin Morell, MD Utica New York
United States Stanley A. Newfield Valley Stream New York
United States Neil S. Heskel, MD Vero Beach Florida
United States Sunnycoast Dermatology Vero Beach Florida
United States Virginia Beach Dermatology Associates, PPLC Virginia Beach Virginia
United States Eastern Washington Dermatology Walla Walla Washington
United States Midwest Center for Dermatology and Cosmetic Surgery Warren Michigan
United States Joel Seigel- MD Washington Pennsylvania
United States Jeffrey Alter Waterbury Connecticut
United States Michael T. Siegel MD- P.C. Waterford Michigan
United States Dermatology Associates Waterloo Iowa
United States Eileen Ringel Waterville Maine
United States Palmetto Dermatology, PA West Columbia South Carolina
United States Paul Getz West Dundee Illinois
United States Randall Dermatology West Lafayette Indiana
United States Alan B Schliftman White Plains New York
United States Moeller Dermatology, LLC Wichita Kansas
United States Sabrina Dowd Williamsport Pennsylvania
United States Colleen Demers Williamsville New York
United States Lynn A. Amarante, MD PC Williamsville New York
United States Atlantic Dermatology Associates, P.A. Wilmington North Carolina
United States Atlantic Skin and Cosmetic Surgery- P.C. Wilmington Delaware
United States WHA Medical Clinic PLLC Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To measure the rates of non-Hodgkin's lymphoma (NHL) and infections that require hospitalization occurring in psoriasis patients treated with alefacept At six month intervals for five years No
Secondary To estimate the rates of lung cancer, breast cancer (female), prostate cancer, colorectal cancer, melanoma and active tuberculosis within a population of patients with psoriasis treated with alefacept. At six month intervals for five years No
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