A One-Year Study To Evaluate The Efficacy And Safety Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
NCT ID: NCT01309737
Last Updated: 2014-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
960 participants
INTERVENTIONAL
2011-03-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Treatment 10 mg BID
CP-690,550
10 mg oral BID, Continuous treatment for 52 Weeks
Active Treatment 5 mg BID
CP-690,550
5 mg oral BID, Continuous treatment for 52 Weeks
Placebo Treatment
Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Interventions
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CP-690,550
10 mg oral BID, Continuous treatment for 52 Weeks
CP-690,550
5 mg oral BID, Continuous treatment for 52 Weeks
Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Placebo/CP-690,550
0 mg oral BID, Continuous Treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Eligibility Criteria
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Inclusion Criteria
* A Psoriasis Area and Severity Index (PASI) score of 12 or greater
* Are considered to be candidates for systemic or light therapy
* Have no evidence of active or latent tuberculosis
Exclusion Criteria
* Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
* Any uncontrolled significant medical condition
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States
University of California San Diego
La Jolla, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Expresscare Medical (X-Rays only)
Los Angeles, California, United States
MedDerm Associates
San Diego, California, United States
University of California San Diego
San Diego, California, United States
Healthcare Partners Medical Group
Torrance, California, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States
Dermatologic Surgery Specialists, PC
Macon, Georgia, United States
Sherman Immediate Care Center (Imaging Only)
Algonquin, Illinois, United States
Schaumburg Dermatology
Schaumburg, Illinois, United States
NorthShore University HealthSystem - Division of Dermatology
Skokie, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
Hudson Dermatology
Evansville, Indiana, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Somerset Skin Centre - Dermcenter
Troy, Michigan, United States
University of Minnesota - Department of Dermatology
Minneapolis, Minnesota, United States
Saint Louis University - Department of Dermatology
St Louis, Missouri, United States
Central Dermatology, PC
St Louis, Missouri, United States
Bettencourt Skin Center
Henderson, Nevada, United States
Dartmouth Hitchcock Medical Center - Section of Dermatology
Lebanon, New Hampshire, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
The Rockefeller University
New York, New York, United States
University of North Carolina at Chapel Hill Hospital
Chapel Hill, North Carolina, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Radiant Research, Inc.
Columbus, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
Austin Dermatology Associates
Austin, Texas, United States
Dermatology Treatment & Research Center, PA
Dallas, Texas, United States
InSight Diagnostic Center
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Suzanne Bruce and Associates, PA
Houston, Texas, United States
Office of Mark S. Lee, MD
San Antonio, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Kirk Barber Research
Calgary, Alberta, Canada
Northwest Dermatology & Laser Centre
Calgary, Alberta, Canada
Stratica Medical
Edmonton, Alberta, Canada
Guildford Dermatology Specialists
Surrey, British Columbia, Canada
Practice office of John D. Amiss MD
Victoria, British Columbia, Canada
PerCuro Clinical Research Ltd
Victoria, British Columbia, Canada
NewLab Clinical Research Inc.
St. John's, Newfoundland and Labrador, Canada
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
CCA Medical Research Corporation
Ajax, Ontario, Canada
Co-Medica Research Network Inc.
Courtice, Ontario, Canada
The Guenther Dermatology Research Centre
London, Ontario, Canada
Oshawa Clinic
Oshawa, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
K.Papp Clinical Research Inc.
Waterloo, Ontario, Canada
XLR8 Medical Research Inc.
Windsor, Ontario, Canada
Siena Medical Research
Montreal, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Facharzt fuer Dermatologie und Allergologie
Berlin, , Germany
Klinische Forschung Berlin-Buch GmbH
Berlin, , Germany
Dres.Kirsten Prepeneit und Volker Streit
Buchholz, , Germany
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt am Main, , Germany
Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
Halle, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter
Hanau, , Germany
Universitaetsklinikum, Schleswig-Holstein, Klinik fuer Dermatologie
Lübeck, , Germany
Hautarztpraxis Dres. Scholz, Sebastian, Schilling
Mahlow, , Germany
Wilhelm Fresenius Klinik
Wiesbaden/ Bierstadt, , Germany
Facharzt fuer Dermatologie, Venerologie, Allergologie, Naturheilverfahren, Lasermedizin
Witten, , Germany
Tolna Megyei Onkormanyzat Balassa Janos Korhaza, Borgyogyaszati Osztaly
Szekszárd, , Hungary
Vas Megyei Markusovszky Korhaz, Borgyogyaszati Osztaly
Szombathely, , Hungary
Veszprem Megyei Csolnoky Ferenc Korhaz, Borgyogyaszat
Veszprém, , Hungary
Instituto Mexicano de Investigacion Clinica, S.A. de C.V
México, D.f., Mexico
Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
Zapopan, Jalisco, Mexico
Centro Medico San Lucas
Monterrey, Nuevo León, Mexico
Specjalistyczne Gabinety Lekarskie "Dermed�
Lodz, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
Klinika Dermatologii Wojskowy Instytut Medyczny
Warsaw, , Poland
The Office of Dr. Alma M. Cruz, MD.
Carolina, , Puerto Rico
Military Medical Academy
Belgrade, , Serbia
Chang Gung Memorial Hospital Kaohsiung branch
Niao-Sung Hsiang, Kaohsiung County, Taiwan
Chang Gung Medical Foundation, Linkou Branch
Kwei-Shan, Taoyuan, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
MIHC Kharkiv City Dermatovenerologic Dispensary #2
Kharkiv, Ukraine, Ukraine
Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
Kyiv, , Ukraine
Lugansk Regional Dermatovenerologic Dispensary
Luhansk, , Ukraine
Lviv regional municipal dermatovenerologic dispensary,
Lviv, , Ukraine
Department of dermatology and venereology of Odessa National Medical University
Odesa, , Ukraine
Countries
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References
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Kristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2.
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
Merola JF, Elewski B, Tatulych S, Lan S, Tallman A, Kaur M. Efficacy of tofacitinib for the treatment of nail psoriasis: Two 52-week, randomized, controlled phase 3 studies in patients with moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2017 Jul;77(1):79-87.e1. doi: 10.1016/j.jaad.2017.01.053. Epub 2017 Apr 7.
Papp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, Langley R, Luger T, Thaci D, Buonanno M, Gupta P, Proulx J, Lan S, Wolk R; OPT Pivotal 1 and OPT Pivotal 2 investigators. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015 Oct;173(4):949-61. doi: 10.1111/bjd.14018.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3921079
Identifier Type: -
Identifier Source: org_study_id
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