Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB (CP-690,550) IN CHINESE SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE CONVENTIONAL SYNTHETIC DMARD
1 other identifier
interventional
204
1 country
38
Brief Summary
This is a 6 month study investigating the effectiveness and safety of tofacitinib in treating signs and symptoms and improving physical function in Chinese patients with active psoriatic arthritis and had inadequate response to a conventional synthetic disease modifying anti-rheumatic drug. This is a China alone study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2018
Typical duration for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedStudy Start
First participant enrolled
August 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2021
CompletedResults Posted
Study results publicly available
February 8, 2024
CompletedFebruary 8, 2024
June 1, 2023
2.7 years
March 5, 2018
March 8, 2022
June 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3
ACR50 response: greater than or equal to (≥) 50% improvement in tender (TJC) and swollen joint counts (SJC) and ≥50% improvement in 3 of the 5 remaining ACR-core set measures: patient (PtGA) and physician global assessments (PhyGA), pain, disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\], scored from 0 to 3), and an acute-phase reactant (C-reactive protein \[CRP\]). TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 millimeter (mm).
Month 3
Secondary Outcomes (31)
Percentage of Participants Achieving ACR20 Response at Week 2, Month 1, 2, 3, 4, and 6
Week 2, Month 1, 2, 3, 4, and 6
Percentage of Participants Achieving ACR70 Response at Week 2, Month 1, 2, 3, 4, and 6
Week 2, Month 1, 2, 3, 4, and 6
Percentage of Participants Achieving ACR50 Response at Week 2, Month 1, 2, 4, and 6
Week 2, Month 1, 2, 4, and 6
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 2, Month 1, 2, 3, 4, and 6
Baseline, Week 2, Month 1, 2, 3, 4, and 6
HAQ-DI Response (Decrease From Baseline ≥0.30) Rate for Participants With Baseline HAQ-DI ≥0.30 at Week 2, Month 1, 2, 3, 4, and 6
Week 2, Month 1, 2, 3, 4, and 6
- +26 more secondary outcomes
Study Arms (2)
Treatment Sequence A
EXPERIMENTALTofacitinib 5 mg BID for 6 months
Treatment Sequence B
PLACEBO COMPARATORPlacebo for 3 months then tofacitinib 5 mg BID for 3 months
Interventions
Eligibility Criteria
You may qualify if:
- Chinese patients
- 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
You may not qualify if:
- Non-plaque forms of psoriasis (with exception of nail psoriasis)
- History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (38)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The First Affiliated Hospital of Anhui Medical University/Rheumatology Department
Hefei, Anhui, 230022, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Army Medical University, PLA
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317, China
The Third Hospital of Hebei Medical University, Rheumatology and Immunology Department
Shijiazhuang, Hebei, 050051, China
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010, China
Department of Rheumatology, The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001, China
Department of Rheumatology ,The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Department of Rheumatology, Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Jiu Jiang No.1 People's Hospital
Jiujiang, Jiangxi, 332000, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
The First hospital of Jilin University
Changchun, Jilin, China
Linyi People's Hospital
Linyi, Shandong, 276003, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Department of Rheumatology and Immunology,West China Hospital，Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital, Rheumatology and Immunology Department
Tianjin, Tianjin Municipality, 300052, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, 200052, China
Related Publications (2)
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.
PMID: 40241921DERIVEDLeng 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.
PMID: 36720560DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2018
First Posted
April 3, 2018
Study Start
August 10, 2018
Primary Completion
April 28, 2021
Study Completion
April 28, 2021
Last Updated
February 8, 2024
Results First Posted
February 8, 2024
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.