A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
NCT ID: NCT01276639
Last Updated: 2014-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
901 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
ActiveTreatment 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 and are considered to be candidates for systemic or light therapy
* 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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Radiant Research, Inc.
Birmingham, Alabama, United States
University of California, Irvine - Dermatology Research
Irvine, California, United States
Skin Surgery Medical Group, Inc.
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Cherry Creek Research, Inc.
Denver, Colorado, United States
The Savin Center, P.C.
New Haven, Connecticut, United States
Renstar Medical Research
Ocala, Florida, United States
Academic Alliance in Dermatology
Tampa, Florida, United States
Atlanta Dermatology, Vein & Research Center, P.C.
Alpharetta, Georgia, United States
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, United States
MedaPhase Inc.
Newnan, Georgia, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin
Boston, Massachusetts, United States
Skin Specialists, P.C.
Omaha, Nebraska, United States
New York University School of Medicine
New York, New York, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Raleigh Radiology Blue Ridge
Raleigh, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Central Sooner Research
Norman, Oklahoma, United States
Baker Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, United States
University of Pittsburgh Medical Center - Department of Dermatology
Pittsburgh, Pennsylvania, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Dermatology Associates of Knoxville, PC
Knoxville, Tennessee, United States
Modern Research Associates, PLLC
Dallas, Texas, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Rockwood Dermatology Center
Spokane, Washington, United States
Rockwood Research Center
Spokane, Washington, United States
Wenatchee Valley Medical Center - Clinical Research Department
Wenatchee, Washington, United States
Madison Skin and Research, Inc.
Madison, Wisconsin, United States
Dermadvances Research
Winnipeg, Manitoba, Canada
Dr. Zohair Tomi PMC Inc.
St. John's, Newfoundland and Labrador, Canada
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, Canada
Ultranova Skincare
Barrie, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Oakville Dermatology Laser Centre
Oakville, Ontario, Canada
Office of Dr. Michael Robern
Ottawa, Ontario, Canada
K.Papp Clinical Research Inc.
Waterloo, Ontario, Canada
CRCMRGilbert Inc., Centre de Dermatologie Maizerets
Québec, Quebec, Canada
Centro de Reumatologia y Ortopedia
Barranquilla, Atlántico, Colombia
Riesgo de Fractura S.A
Bogot, Cundinamarca, Colombia
Charite - Universitaetsmedizin Berlin
Berlin, , Germany
Aerztehaus "Rudolf Virchow"
Berlin, , Germany
Klinik und Poliklinik fuer Dermatologie und Allergologie der Universitaet Bonn
Bonn, , Germany
Universitaetsklinik Carl Gustav Carus
Dresden, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Praxisklinik fuer Dermatologie, Allergologie und Venenheilkunde
Vechta, , Germany
Facharzt fuer Dermatologie und Venerologie, Allergologie
Wuppertal, , Germany
Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
Kecskemét, , Hungary
Josa Andras Oktatokorhaz, Borgyogyaszat
Nyíregyháza, , Hungary
Pecsi Tudomanyegyetem/Bor-, Nemikortani es Onkodermatologiai Klinika
Pécs, , Hungary
Gunma University Hospital
Maebashi, Gunma, Japan
JR Sapporo hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Chūōku, Kobe, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Social Insurance Chuo General Hospital
Shinjyuku-ku, Tokyo, Japan
Centro de Dermatologia de Monterrey
Monterrey, Nuevo León, Mexico
Poznanski Osrodek Medyczny
Poznan, , Poland
Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny
Szczecin, , Poland
Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
Wroclaw, , Poland
Oddzial Dermatologiczny
Wroclaw, , Poland
Clinical Hospital Center Zvezdara
Belgrade, , Serbia
National Cheng-Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I. Georgiyevskyj"
Simferopol, Autonomous Republic of Crimea, Ukraine
Dept of Dermatology, Infectious and Parasitic Skin Diseases
Kharkiv, Ukraine, Ukraine
Ternopil Regional Clinical Dermatovenerologic Dispensary
Ternopil, Ukraine, Ukraine
Dept of Dermatology and Venereology of National Medical University n.a. O.O. Bogomolets
Kyiv, , Ukraine
Countries
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References
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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.
Wolk R, Armstrong EJ, Hansen PR, Thiers B, Lan S, Tallman AM, Kaur M, Tatulych S. Effect of tofacitinib on lipid levels and lipid-related parameters in patients with moderate to severe psoriasis. J Clin Lipidol. 2017 Sep-Oct;11(5):1243-1256. doi: 10.1016/j.jacl.2017.06.012. Epub 2017 Jun 24.
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.
Tan H, Valdez H, Griffins CE, Mrowietz U, Tallman A, Wolk R, Gordon K. Early clinical response to tofacitinib treatment as a predictor of subsequent efficacy: Results from two phase 3 studies of patients with moderate-to-severe plaque psoriasis. J Dermatolog Treat. 2017 Feb;28(1):3-7. doi: 10.1080/09546634.2016.1214671. Epub 2016 Aug 18.
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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Other Identifiers
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A3921078
Identifier Type: -
Identifier Source: org_study_id
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