Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
NCT ID: NCT03486457
Last Updated: 2024-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
204 participants
INTERVENTIONAL
2018-08-10
2021-04-28
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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Treatment Sequence A
Tofacitinib 5 mg BID for 6 months
Tofacitinib
tablets, 5 mg BID x 6 months
Treatment Sequence B
Placebo for 3 months then tofacitinib 5 mg BID for 3 months
Placebo
tablets, to match tofacitinib 5 mg BID x 3 months
Tofacitinib
tablets, 5 mg BID x 3 months
Interventions
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Tofacitinib
tablets, 5 mg BID x 6 months
Placebo
tablets, to match tofacitinib 5 mg BID x 3 months
Tofacitinib
tablets, 5 mg BID x 3 months
Eligibility Criteria
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Inclusion Criteria
* Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints
* Active plaque psoriasis at screening
* Inadequate response to at least one conventional synthetic DMARD
Exclusion Criteria
* History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
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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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University/Rheumatology Department
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Army Medical University, PLA
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China
The Third Hospital of Hebei Medical University, Rheumatology and Immunology Department
Shijiazhuang, Hebei, China
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Department of Rheumatology, The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Department of Rheumatology ,The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Department of Rheumatology, Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Jiu Jiang No.1 People's Hospital
Jiujiang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The First hospital of Jilin University
Changchun, Jilin, China
Linyi People's Hospital
Linyi, Shandong, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Department of Rheumatology and Immunology,West China Hospital，Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital, Rheumatology and Immunology Department
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University
Beijing, , China
Huashan Hospital, Fudan University
Shanghai, , China
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, , China
Countries
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References
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Gladman DD, Dougados M, Marzo-Ortega H, Cadatal MJ, Agarwal E, Kinch CD, Nash P. Long-term tofacitinib efficacy and safety in psoriatic arthritis with or without prior biologic DMARD exposure: a post hoc analysis. Rheumatol Adv Pract. 2025 Jan 21;9(2):rkaf008. doi: 10.1093/rap/rkaf008. eCollection 2025.
Leng X, Lin W, Liu S, Kanik K, Wang C, Wan W, Jiang Z, Liu Y, Liu S, Zhang Z, Zhang Z, Xu J, Tan W, Hu J, Li J, Liu J, Gunay LM, Dina O, Kinch C, Zeng X. Efficacy and safety of tofacitinib in Chinese patients with active psoriatic arthritis: a phase 3, randomised, double-blind, placebo-controlled study. RMD Open. 2023 Jan;9(1):e002559. doi: 10.1136/rmdopen-2022-002559.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3921234
Identifier Type: -
Identifier Source: org_study_id
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