Clinical trial NCT03486457: Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: psoriatic arthritis
tofacitinib
China
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-04-03
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3
timeFrame: Month 3
Secondary outcomes:
measure: Percentage of Participants Achieving ACR20 Response at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Week 2, Month 1, 2, 3, 4, and 6
measure: Percentage of Participants Achieving ACR70 Response at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Week 2, Month 1, 2, 3, 4, and 6
measure: Percentage of Participants Achieving ACR50 Response at Week 2, Month 1, 2, 4, and 6
timeFrame: Week 2, Month 1, 2, 4, and 6
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
measure: 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
timeFrame: Week 2, Month 1, 2, 3, 4, and 6
measure: HAQ-DI Response (Decrease From Baseline ≥0.35) Rate for Participants With Baseline HAQ-DI ≥0.35 at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Week 2, Month 1, 2, 3, 4, and 6
measure: Change From Baseline in Swollen Joint Count at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
measure: Change From Baseline in Tender/Painful Joint Count at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
measure: Change From Baseline in Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
measure: Change From Baseline in Patient's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
measure: Change From Baseline in Physician's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
measure: Change From Baseline in CRP at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
measure: Physician's Global Assessment of Psoriasis (PGA-PsO) Response Rates for Participants With Baseline PGA-PsO ≥2 at Month 1, 3 and 6
timeFrame: Month 1, 3 and 6
measure: Change From Baseline in PGA-PsO for Participants With Baseline PGA-PsO>0 at Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3 and 6
measure: Psoriasis Area and Severity Index (PASI) 75 Response Rates at Month 1, 3 and 6 in Participants With Baseline Psoriatic Body Surface Area (BSA) ≥3% and Baseline PASI >0
timeFrame: Month 1, 3 and 6
measure: Percent Change From Baseline in PASI Score at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0
timeFrame: Baseline, Month 1, 3 and 6
measure: Percent Change From Baseline in PASI Clinical Component Scores at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0
timeFrame: Baseline, Month 1, 3 and 6
measure: Percent Change From Baseline in BSA at Month 1, 3 and 6 for Participants With Baseline BSA >0%
timeFrame: Baseline, Month 1, 3 and 6
measure: Change From Baseline in Physician's Global Assessment of Psoriatic Arthritis (PGA-PsA) (VAS) at Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3 and 6
measure: Resolution Rate of Dactylitis at Month 1, 3 and 6 for Participants With Baseline Dactylitis Severity Score (DSS) >0
timeFrame: Month 1, 3 and 6
measure: Change From Baseline in DSS for Participant With Baseline DSS >0 at Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3 and 6
measure: Resolution Rate of Enthesitis at Month 1, 3 and 6 for Participants With Baseline Leeds Enthesitis Index (LEI) >0
timeFrame: Month 1, 3 and 6
measure: Change From Baseline in LEI for Participant With Baseline LEI >0 at Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3 and 6
measure: Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Month 1, 3 and 6 for Participants With Baseline NAPSI >0
timeFrame: Baseline, Month 1, 3 and 6
measure: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Week 2, Month 1, 2, 3, 4, and 6
measure: Change From Baseline in Disease Activity Score (DAS)28-3 (CRP) at Week 2, Month 1, 2, 3, 4, and 6
timeFrame: Baseline, Week 2, Month 1, 2, 3, 4, and 6
measure: Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3 and 6
measure: Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3 and 6
measure: Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score at Month 1, 3 and 6
timeFrame: Baseline, Month 1, 3 and 6
measure: Change From Baseline in Work Productivity and Activity Impairment-Psoriatic Arthritis (WPAI-PsA) at Month 3 and 6: Work Time Missed, Impairment While Working, Overall Work Impairment
timeFrame: Baseline, Month 3 and 6
measure: Change From Baseline in WPAI-PsA at Month 3 and 6: Activity Impairment
timeFrame: Baseline, Month 3 and 6
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University/Rheumatology Department
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Army Medical University, PLA
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University, Rheumatology and Immunology Department
state: Hebei
city: Harbin
country: China
facility: Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Changzhou
country: China
facility: Department of Rheumatology, The First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Suzhou
country: China
facility: Department of Rheumatology ,The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Yangzhou
country: China
facility: Department of Rheumatology, Northern Jiangsu People's Hospital
state: Jiangsu
city: Jiujiang
country: China
facility: Jiu Jiang No.1 People's Hospital
state: Jiangxi
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First hospital of Jilin University
state: Jilin
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Department of Rheumatology and Immunology,West China Hospital，Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital, Rheumatology and Immunology Department
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
city: Shanghai
country: China
facility: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: