Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT ID: NCT00678210
Last Updated: 2012-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
197 participants
INTERVENTIONAL
2008-07-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
CP-690,550
tablets, 2 mg BID for 12 weeks
2
CP-690,550
tablets, 5 mg BID for 12 weeks
3
CP-690,550
tablets, 15 mg BID for 12 weeks
4
Placebo
tablets, BID for 12 weeks
Interventions
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CP-690,550
tablets, 2 mg BID for 12 weeks
CP-690,550
tablets, 5 mg BID for 12 weeks
CP-690,550
tablets, 15 mg BID for 12 weeks
Placebo
tablets, BID for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Have plaque psoriasis covering at least 15% of their total body.
* Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
* Be willing and able to comply with scheduled visits, treatment plan and other study procedures.
Exclusion Criteria
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy.
* Subject is participating in another trial using an investigational agent or procedure.
* Women who are pregnant or breast-feeding or considering becoming pregnant.
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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Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Oceanside, California, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
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Miami, Florida, United States
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West Dundee, Illinois, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
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St Louis, Missouri, United States
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East Windsor, New Jersey, United States
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Paramus, New Jersey, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Norman, Oklahoma, United States
Pfizer Investigational Site
Lake Oswego, Oregon, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
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Greer, South Carolina, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Webster, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Vancouver, British Columbia, Canada
Pfizer Investigational Site
Moncton, New Brunswick, Canada
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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London, Ontario, Canada
Pfizer Investigational Site
North Bay, Ontario, Canada
Pfizer Investigational Site
Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
Pfizer Investigational Site
Laval, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Québec, Quebec, Canada
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.
Valenzuela F, Papp KA, Pariser D, Tyring SK, Wolk R, Buonanno M, Wang J, Tan H, Valdez H. Effects of tofacitinib on lymphocyte sub-populations, CMV and EBV viral load in patients with plaque psoriasis. BMC Dermatol. 2015 May 8;15:8. doi: 10.1186/s12895-015-0025-y.
Menter A, Papp KA, Tan H, Tyring S, Wolk R, Buonanno M. Efficacy of tofacitinib, an oral janus kinase inhibitor, on clinical signs of moderate-to-severe plaque psoriasis in different body regions. J Drugs Dermatol. 2014 Mar;13(3):252-6.
Bushmakin AG, Mamolo C, Cappelleri JC, Stewart M. The relationship between pruritus and the clinical signs of psoriasis in patients receiving tofacitinib. J Dermatolog Treat. 2015 Feb;26(1):19-22. doi: 10.3109/09546634.2013.861891. Epub 2013 Dec 2.
Strober B, Buonanno M, Clark JD, Kawabata T, Tan H, Wolk R, Valdez H, Langley RG, Harness J, Menter A, Papp K. Effect of tofacitinib, a Janus kinase inhibitor, on haematological parameters during 12 weeks of psoriasis treatment. Br J Dermatol. 2013 Nov;169(5):992-9. doi: 10.1111/bjd.12517.
Papp KA, Menter A, Strober B, Langley RG, Buonanno M, Wolk R, Gupta P, Krishnaswami S, Tan H, Harness JA. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo-controlled dose-ranging study. Br J Dermatol. 2012 Sep;167(3):668-77. doi: 10.1111/j.1365-2133.2012.11168.x.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3921047
Identifier Type: -
Identifier Source: org_study_id