A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis
NCT ID: NCT01815424
Last Updated: 2019-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
266 participants
INTERVENTIONAL
2013-12-31
2015-07-31
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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Placebo BID
placebo
placebo BID for 16 weeks and then re-randomized into active groups
5mg BID CP-690,550
CP-690,550
CP-690,550 5mg BID for 52 weeks
10mg BID CP-690,550
CP-690,550
CP-690,550 10mg BID for 52 weeks
Interventions
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placebo
placebo BID for 16 weeks and then re-randomized into active groups
CP-690,550
CP-690,550 5mg BID for 52 weeks
CP-690,550
CP-690,550 10mg BID for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline (Day 1).
* Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment).
Exclusion Criteria
* Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
* Subjects who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) for the study are excluded.
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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Dept. Of dermatology &STD, Beijing Friendship Hospital, Capital Medical University
Xicheng District, Beijing Municipality, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hospital of Skin Diseases, Chinese Academy of Medical Sciences
Nanjing, Jiangsu, China
Department of Dermatology, The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Huashan Hospital, Fudan University/Dermatology Department
Shanghai, Shanghai Municipality, China
Shanghai Changhai Hospital, Dermatology Department
Shanghai, Shanghai Municipality, China
Dermatology Department, The First Affiliated Hospital, The Fourth Military Medical University
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Peking University First Hospital / The Department of Dermatology
Beijing, , China
Peking University People's Hospital/Dermatology Department
Beijing, , China
Beijing Hospital of the Ministry of Health/Department of Dermatology
Beijing, , China
Peking Union Medical College Hospital/Department of Dermatology
Beijing, , China
Tianjin Medical University General Hospital, Dermatological Department
Tianjin, , China
Seoul National University Hospital
Seoul, , South Korea
Department of Dermatology,Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
National Cheng-Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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References
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Zhang J, Tsai TF, Lee MG, Zheng M, Wang G, Jin H, Gu J, Li R, Liu Q, Chen J, Tu C, Qi C, Zhu H, Ports WC, Crook T. The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study. J Dermatol Sci. 2017 Oct;88(1):36-45. doi: 10.1016/j.jdermsci.2017.05.004. Epub 2017 May 16.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3921174
Identifier Type: -
Identifier Source: org_study_id
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