PsoriasisATLASNCT00454701
Assessment and Tracking of Long-term Alefacept Safety
An observational study of Psoriasis, run by Astellas Pharma Inc at 268 sites in 2 countries.
Trial summary
Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months to gather general health information. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Alefacept exposure
- How many people
- 1,897 participants
- Where
- 268 sitesin 2 countries
- Study dates
- Jun 2003to Feb 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with alefacept for chronic plaque psoriasis
Who may be able to join
- Psoriasis patients who are prescribed alefacept consistent with product labeling are eligible for enrollment.
Who cannot join
None listed.
Trial locations and contacts
268 sites in 2 countries.
268 sites in 2 countries
United States241 sites
Paul S. Takiguchi- MD- Inc.
‘Aiea, Hawaii, 96701
Davie Dermatology
Advance, North Carolina, 27006
Derm & Skin Cancer Surgery Center
Allen, Texas, 75013
Jerri L. Johnson MD, PA
Altamonte Springs, Florida, 32701
Arlington Center for Dermatology
Arlington, Texas, 76011
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
Skyland Dermatology and Psychiatry
Asheville, North Carolina, 28803
William S. Mirando, MD, LLC
Ashtabula, Ohio, 44004-4985
Emory University School of Medicine
Atlanta, Georgia, 30322
Darren Casey
Atlanta, Georgia, 30327
Georgia Skin Specialists
Atlanta, Georgia, 30327
Peachtree Dermatology Associates
Atlanta, Georgia, 30327
Family Dermatology-Cynthia A. Abbott, MD
Atlanta, Georgia, 30328
Midsouth Dermatology and Skin Cancer Center
Bartlett, Tennessee, 38134
LA Dermatology Assoc LLC
Baton Rouge, Louisiana, 70809
Dermatology Associates of the Low Counties
Beaufort, South Carolina, 29907
Robert M. Stiegel- M.D. LTD
Beaver, Pennsylvania, 15009
Benjamin Bernstein
Bel Air, Maryland, 21014
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Dermatology & Laser Center Northwest
Bellingham, Washington, 98225
Lehigh Valley Dermatology
Bethlehem, Pennsylvania, 18018
Northeast Dermatology
Beverly, Massachusetts, 01915
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35205
Janet Cash
Birmingham, Alabama, 35213
Thomas Brander
Bloomington, Illinois, 61701
Advanced Dermatology Associates, PC
Bloomington, Indiana, 47403
Center for Dermatology
Boca Raton, Florida, 33428
Jodi Fiedler
Boca Raton, Florida, 33428
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Advanced Skin & Laser Center
Brentwood, Tennessee, 37027
Jeremy Moss, MD
Bridgeport, Connecticut, 06606
Buffalo Medical Group
Buffalo, New York, 14221
Jeffrey N Samuelson
Burnsville, Minnesota, 55337
Calumet Dermatology Associates S.C.
Calumet City, Illinois, 60409
Dermatology and Skin Surgery Center, PA
Celebration, Florida, 34747
Advanced Dermatology
Centennial, Colorado, 80111
Eugene Conte
Centerville, Ohio, 45459
Christie Clinic
Champaign, Illinois, 61820
Marta Hampton
Charleston, South Carolina, 29407
Rheumatology Associates
Charleston, South Carolina, 29407
Curtis W. Schupbach- MD
Charlotte, North Carolina, 28204
The Dermatology Group LLC
Chevy Chase, Maryland, 20815
Cheyenne Dermatology- P.C.
Cheyenne, Wyoming, 82001
Danilo Del Campo
Chicago, Illinois, 60641
University Dermatology Consultants, Inc.
Cincinnati, Ohio, 45242
Wendy McFalda, DO
Clarkston, Michigan, 48346
Drs. Iacobelli & DiGregorio, PC
Clinton Township, Michigan, 48038
The Dermatology Group, LLC
Columbia, South Carolina, 29201
McClerklin Skin and Laser Center
Columbia, South Carolina, 29203
Allen B. Filstein, MD
Conyers, Georgia, 30012
East Metro Dermatology, PC
Conyers, Georgia, 30012
Melissa Knuckles
Corbin, Kentucky, 40701
Alpha Therapy Center
Corpus Christi, Texas, 78404
Spencer Dermatology Associates LLC
Crawfordsville, Indiana, 47933
Mitchell Bressack
Crown Point, Indiana, 46307
Raymond Blackburn
Dallas, Texas, 75235
Martha Hickmann, MD
Dayton, Ohio, 45459
Brent M Schillinger
Delray Beach, Florida, 33483
Dermatology & Laser Center at Harvard Park, PLLC
Denver, Colorado, 80210
North Atlanta Dermatology
Duluth, Georgia, 30096
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, 08520
Advancements In Derm
Edina, Minnesota, 55435
Michael A. Greenberg, MD, Ltd.
Elk Grove Village, Illinois, 60007
Dermatology & Advanced Skin Care
Ellicott City, Maryland, 21043
Joyce Lender
Elyria, Ohio, 44035
Jan Brydon
Erie, Pennsylvania, 16507
Bay Shore Dermatology & Laser Surgery Center
Fairhope, Alabama, 36532
Ozark Dermatology Clinic
Fayetteville, Arkansas, 72703
Bruce Goldstein
Florence, Massachusetts, 01062
Bruce S. Stein
Flushing, New York, 11355
Cyril E Severns
Fort Smith, Arkansas, 72902
Fort Wayne Dermatology
Fort Wayne, Indiana, 46804
Betty J. Rajan
Fort Worth, Texas, 76107
East Bay Dermatology Medical Group Inc. DBA Center for Dermatology, Cosmetic & Laser Surgery, Inc
Fremont, California, 94538
East Bay Dermatology Medical Group Inc., DBA Center for Dermatology, Cosmetic and Laser Surgery
Fremont, California, 94538
Advanced Dermatology
Fresh Meadows, New York, 11365
Minarets Medical Group, Inc.
Fresno, California, 93711
Jack C. Scott
Fridley, Minnesota, 55432
Steven E. Prawer
Fridley, Minnesota, 55432
Eric Baum
Gadsden, Alabama, 35901
Northeast Dermatology & Cosmetic Surgery
Gahanna, Ohio, 43230
Frank De Mento
Garden City, New York, 11530
Garden City Dermatology, P.C.
Garden City, New York, 11530
Lisa Garner
Garland, Texas, 75043
John J. Guagenti, MD
Glendale, California, 91204
Rivergate Dermatology Research Center
Goodlettsville, Tennessee, 37072
D.B.A. Colorado West Dermatology
Grand Junction, Colorado, 81501
Psoriasis and Eczema Treatment Center of Western Michigan
Grand Rapids, Michigan, 49503
Layton Avenue Dermatology
Greenfield, Wisconsin, 53221
John Humeniuk
Greenville, South Carolina, 29605
Dimitri Dermatology
Gretna, Louisiana, 70056
Eric R. Wolf, MD
Groton, Connecticut, 06340
The Dermatology Clinic- PLLC
Gulfport, Mississippi, 39503
North Suburban Dermatology Associates
Gurnee, Illinois, 60031
David Amato
Harrisburg, Pennsylvania, 17109
Saye & Gette Dermatology Associates, PC
Harrisburg, Pennsylvania, 17112
Mark Gallardo
Hattiesburg, Mississippi, 39402
Great Plains Dermatology- P.A.
Hays, Kansas, 67601
Associated Dermatology
Helena, Montana, 59601
Chad Mathews
Hermitage, Pennsylvania, 16148
A.G.A. Clinical Trials
Hialeah, Florida, 33012
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
West Houston Dermatology, PA
Houston, Texas, 77082
Lone Star Children's Medical PLLC
Houston, Texas, 77092
Edmund Lee
Huntington, New York, 11743
Ruth A Yates
Huntsville, Alabama, 35801
Tsu-Yi Chuang
Indianapolis, Indiana, 46202
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Dermatology and Laser Center
Irving, Texas, 75061
North Florida Dermatology Associates, P.A.
Jacksonville, Florida, 32204
Coastal Dermatology, PA
Jacksonville, Florida, 32246
Jeffrey P Schachne
Jefferson Valley, New York, 10535
Clinical Partners, LLC
Johnston, Rhode Island, 02919
A Center for Dermatology, Cosmetic and Laser Surgery
Jupiter, Florida, 33458
Andrew Berg
Kansas City, Missouri, 64114-4846
Dermatology Associates of Kingsport, PC
Kingsport, Tennessee, 37660
Steven J. Smith, MD
Kingwood, Texas, 77339
Dermatology Associates of Knoxville, PC
Knoxville, Tennessee, 37922
Scripps Clinic
La Mesa, California, 91941
Dermatology Associates of LaGrange
LaGrange Highlands, Illinois, 60525
Allergy, Asthma & Dermatology Research Centers, LLC
Lake Oswego, Oregon, 97035
Dermatology Associates of Lancaster
Lancaster, Pennsylvania, 17601
Stephanie Mackey
Lancaster, Pennsylvania, 17602
Johnnie M Woodson
Las Vegas, Nevada, 89128
Study site
Las Vegas, Nevada, 89128
Robert B. Stromling, MD
Las Vegas, Nevada, 89144
Little Rock Dermatology Clinic
Little Rock, Arkansas, 72205
Livonia Dermatology, PLLC
Livonia, Michigan, 48154
Fairmont Dermatology
Lodi, California, 95242
Rocky Mountain Dermatology
Logan, Utah, 84341
Mark S Wallis
Longview, Texas, 75604
Lubbock Dermatology and Skin Cancer Center
Lubbock, Texas, 79410
Dermatology of East Texas
Lufkin, Texas, 75904
Atlantic Dermatologic Associates, LLC
Lynbrook, New York, 11563
Dermatologic Surgery Specialist Inc.
Macon, Georgia, 31217
Mark Lewis
Marblehead, Massachusetts, 01945
Delta Medical Ctr.
Memphis, Tennessee, 38120
Mobile Dermatology
Mobile, Alabama, 36609
Orange Dermatology Assoc, PC
Monroe, New York, 10950
Allegheny Dermatology Assoc., PC
Monroeville, Pennsylvania, 15146
California Skin Institute
Mountain View, California, 94040
Lesly S. Davidson MD PA
Mt. Pleasant, South Carolina, 29464
Grand Strand Dermatology, LLC
Myrtle Beach, South Carolina, 29588
Saltzer Medical Group, PA
Nampa, Idaho, 83687
Associates in Medical and Surgical Dermatology
Naples, Florida, 34109
Nashua Dermatology Associates
Nashua, New Hampshire, 03062
Abigail James, NP, MSN
Nashville, Tennessee, 37205
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Jay A. Goldstein, MD
Natick, Massachusetts, 01760
Peter S. Halperin's Office
New York, New York, 10021
Panzer Dermatology Assoc.
Newark, Delaware, 19713
East Penn Dermatology
North Wales, Pennsylvania, 19454
Bender and Kolenik MD, PC
Norwalk, Connecticut, 06851
Charles Halasz
Norwalk, Connecticut, 06851
Stuart Bender
Norwalk, Connecticut, 06851
Dermatology & Laser Center
Orange Park, Florida, 32073
Hillcrest Dermatology Center, PA
Orangeburg, South Carolina, 29118
Peter Accetta
Orchard Park, New York, 14127
Aspen Clinical Research, LLC
Orem, Utah, 84058
Reflections Dermatology & Center for Skin Care
Orlando, Florida, 32814
John L. Meisenheimer, MD
Orlando, Florida, 32819
Advanced Dermatology
Orlando, Florida, 32828
Ormond Beach Dermatology
Ormond Beach, Florida, 32174
Waters Edge Dermatology
Palm Beach Gardens, Florida, 33410
Mark Cheiken
Palm Coast, Florida, 32137
Timothy Kelly, MD, PA
Palm Harbor, Florida, 34684
Ashkan Ghorbani
Pasadena, Texas, 77504
Paul T. Zaydon MD
Pawtucket, Rhode Island, 02861
Snyder & Le M.D. PA
Pembroke Pines, Florida, 33028
Kevin L Welch
Pensacola, Florida, 32514
Soderstrom Dermatology Center
Peoria, Illinois, 61614
David Coynik
Peru, Illinois, 61354
Paddington Testing Co, Inc.
Philadelphia, Pennsylvania, 19103
English Dermatology Centers
Phoenix, Arizona, 85044
Louis H. Martone, MD, PC
Pittsburgh, Pennsylvania, 15215
Neil M. Niren MD
Pittsburgh, Pennsylvania, 15237
Dermatology Associates of Plymouth Meeting- P.C.
Plymouth Meeting, Pennsylvania, 19462
Hecker Dermatology Group PA
Pompano Beach, Florida, 33064
Kenneth M. Reed, MD
Quincy, Massachusetts, 02169
Andrus & Associates Dermatology, PA
Raleigh, North Carolina, 27609
Aylesworth Dermatology SC
Rhinelander, Wisconsin, 54501
Georgia A Seely
Richmond, Virginia, 23225
North Bergen Dermatologic Group
Ridgewood, New Jersey, 07450
Dermatology Partners of Western New York
Rochester, New York, 14607
Greater Washington Dermatology P.A.
Rockville, Maryland, 20850
Todd Colonna
Rockville, Maryland, 20850
Gregory W Thompson
San Antonio, Texas, 78232
Clinical Research Specialists, Inc.
Santa Monica, California, 90404
Schaumburg Dermatology
Schaumburg, Illinois, 60194
Scottsdale Dermatology
Scottsdale, Arizona, 85251
Dermatology Associates, PLLC
Seattle, Washington, 98101
James Hu MD PC
Seattle, Washington, 98104
Joseph Bikowski
Sewickley, Pennsylvania, 15143
American Dermatology Associates
Shawnee, Kansas, 66216
Alan E. Lasser MD PC
Skokie, Illinois, 60077
Dermatique Dermedy Dermatology- PC
Smithtown, New York, 11787
Marina I Peredo, MD
Smithtown, New York, 11787
Four Seasons Dermatology
South Burlington, Vermont, 05403
DeVore Dermatology, PA
Spartanburg, South Carolina, 29307
Ronald S. Nadel
Springfield, Massachusetts, 01107
Eric Olson
Springfield, Oregon, 97477
Sharon K Tiefenbrunn
St Louis, Missouri, 63109
Josiane Lederman, MD, PC
Staten Island, New York, 10314
Judith Andreano
Strongsville, Ohio, 44136
Joseph D. Sutton, MD
Suffern, New York, 10901
Harvey L. Handler, MD
Sylvania, Ohio, 43560
James M. Komorous MD PS
Tacoma, Washington, 98405
Michael A. Scannon MD, PA
Tampa, Florida, 33607
Luis T. Menendez, MD, PA
Tampa, Florida, 33609
Susan E. Katz MD
The Bronx, New York, 10461
Medical College of Ohio
Toledo, Ohio, 43614
Kansas Medical Clinic, PA
Topeka, Kansas, 66614
Somerset Skin Centre
Troy, Michigan, 48084
Paul Klas
Tualatin, Oregon, 97062
Sheftel & Associates Dermatology
Tucson, Arizona, 85718
Options Health Research
Tulsa, Oklahoma, 74104
Dermatology Research Associates of Tyler
Tyler, Texas, 75703
Timothy Abrahamson
Urbandale, Iowa, 50323
Martin Morell, MD
Utica, New York, 13502
Stanley A. Newfield
Valley Stream, New York, 11581
Neil S. Heskel, MD
Vero Beach, Florida, 32960
Sunnycoast Dermatology
Vero Beach, Florida, 32960
Virginia Beach Dermatology Associates, PPLC
Virginia Beach, Virginia, 23464
Eastern Washington Dermatology
Walla Walla, Washington, 99362
Midwest Center for Dermatology and Cosmetic Surgery
Warren, Michigan, 48093
Joel Seigel- MD
Washington, Pennsylvania, 15301
Jeffrey Alter
Waterbury, Connecticut, 06708
Michael T. Siegel MD- P.C.
Waterford, Michigan, 48328
Dermatology Associates
Waterloo, Iowa, 50702
Eileen Ringel
Waterville, Maine, 04901
Palmetto Dermatology, PA
West Columbia, South Carolina, 29169
Paul Getz
West Dundee, Illinois, 60118
Randall Dermatology
West Lafayette, Indiana, 47906
Alan B Schliftman
White Plains, New York, 10604
Moeller Dermatology, LLC
Wichita, Kansas, 67206
Sabrina Dowd
Williamsport, Pennsylvania, 17701
Colleen Demers
Williamsville, New York, 14221
Lynn A. Amarante, MD PC
Williamsville, New York, 14221
Atlantic Skin and Cosmetic Surgery- P.C.
Wilmington, Delaware, 19810
Atlantic Dermatology Associates, P.A.
Wilmington, North Carolina, 28401
WHA Medical Clinic PLLC
Wilmington, North Carolina, 28401
Canada27 sites
Clinique de dermatologie Dr. Francois Bouchard
Alma, Quebec, G8B 2V5
Francoise Giard
Gatineau, Quebec, J8T 7W3
Sudbury Skin Clinic
Greater Sudbury, Ontario, P3E 5M4
Dermatrials Research
Hamilton, Ontario, L8N 1V6
Limestone Dermatology & Laser Clinic
Kingston, Ontario, K7L 1S2
Mediprobe Research, Inc.
London, Ontario, N5X 2P1
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
Wellington Dermatology Associates
London, Ontario, N6H 1S9
Lynderm Research, Inc.
Markham, Ontario, L3P 1A8
Innovaderm Research, Inc
Montreal, Quebec, H2K 4L5
Siena Medical Research
Montreal, Quebec, H3Z 2S6
John J. Turner, MD
Newmarket, Ontario, L3Y 5G8
A.M. Katz Medicine D.C.
Newmarket, Ontario, L3Y 6P5
Dermatology Clinic
North York, Ontario, M3K 1Z1
Skin Centre for Dermatology
Peterborough, Ontario, K9J 1Z2
Giles P. Raymond
Pierrefonds, Quebec, H8Z 1W5
CRCMR Gilbert Inc.
Québec, Quebec, G1J 1X7
(CRDQ) Centre De Recherche Dermatologique Du Quebec Metropolitan
Québec, Quebec, G1V 4X7
Douglas N. Keeling MD Dermatologist PC
Quispamsis, New Brunswick, E2E 4Z4
Victoria East Medical Clinic
Regina, Saskatchewan, S4V 3A6
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8
Study site
St. John's, Newfoundland and Labrador, A1B 3E1
NewLab Clinical Research, Inc.
St. John's, Newfoundland and Labrador, A1C 2H5
Dermatology Associates
Toronto, Ontario, M3H 3S3
Specialized Dermatology
Welland, Ontario, L3C 3W4
Winnipeg Clinic
Winnepeg, Manitoba, R3C 0N2
Dermadvances Research
Winnipeg, Manitoba, R3C 1R4
About this study
Official title: Assessment and Tracking of Long-term Alefacept (LFA-3/IgG1 Fusion Protein) Safety (ATLAS)
Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months to gather general health information.
Read the detailed 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.
- Conditions
- Psoriasis
- Being tested
- Alefacept exposure
- Keywords
- Psoriasis, Alefacept, Amevive®, Drug exposure
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alefacept exposureDrug
Also called Amevive, ASP0485
Observational
| Study group | Role | What they receive |
|---|---|---|
| 1. Amevive Exposure | Patients treated with alefacept for chronic plaque psoriasis Receives: Drug: Alefacept exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the rates of non-Hodgkin's lymphoma (NHL) and infections that require hospitalization occurring in psoriasis patients treated with alefacept
Measured: At six month intervals for five years
Secondary outcomes (1)
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.
Measured: At six month intervals for five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startJun 2003
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive
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.
- 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
- 1,897 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vice President Medical Affairs, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454701
- Sponsor's protocol ID
- 0485-CL-0001
- Other IDs
- C-736
- Acronym
- ATLAS
- Status last verified
- Dec 2013
- First submitted
- 29 Mar 2007
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Tracking of Long-term Alefacept (LFA-3/IgG1 Fusion Protein) Safety (ATLAS)
- ClinicalTrials.gov ID
- NCT00454701
- Acronym / sponsor ID
- ATLAS / 0485-CL-0001
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Alefacept, Amevive®, Drug exposure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive
- Enrolment
- 1,897 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Apr 2007 (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.
Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months to gather general health information.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. Amevive Exposure | – | Drug: Alefacept exposurePatients treated with alefacept for chronic plaque psoriasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with alefacept for chronic plaque psoriasis
Key inclusion criteria (1 listed)
- Psoriasis patients who are prescribed alefacept consistent with product labeling are eligible for enrollment.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alefacept exposureAlso: Amevive, ASP0485Observational | Drug | 1. Amevive Exposure |
Primary outcome
To measure the rates of non-Hodgkin's lymphoma (NHL) and infections that require hospitalization occurring in psoriasis patients treated with alefacept
Time frame: At six month intervals for five years
1 secondary outcome
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.
Time frame: At six month intervals for five years
Results and safety
The study was stopped early (reason given: The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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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.
Vice President Medical Affairs study director
Astellas Pharma Global Development
268 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Astellas Pharma Inc at 268 sites in 2 countries.
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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 268 sites in United States, Canada. 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 was stopped early (reason given: The Sponsor has made a decision, driven by business needs, to cease promotion, manufacturing, distribution and sales of Amevive). Results are not available in the source record.
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.
What does the primary outcome measure?
To measure the rates of non-Hodgkin's lymphoma (NHL) and infections that require hospitalization occurring in psoriasis patients treated with alefacept (time frame: At six month intervals for five years). It is what the study was designed to measure, not a finding.
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 11 Dec 2013.