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Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tofacitinib
Placebo
Tofacitinib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring psoriatic arthritis, tofacitinib, China

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Bengbu Medical College
  • Anhui Provincial Hospital
  • The First Affiliated Hospital of Anhui Medical University/Rheumatology Department
  • Peking University First Hospital
  • Peking Union Medical College Hospital
  • The First Affiliated Hospital of Army Medical University, PLA
  • The First Affiliated Hospital of Xiamen University
  • The First Affiliated Hospital, Sun Yat-sen University
  • Guangzhou First People's Hospital
  • Guangdong Second Provincial General Hospital
  • The Third Hospital of Hebei Medical University, Rheumatology and Immunology Department
  • Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
  • The First Affiliated Hospital of Zhengzhou University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Xiangya Hospital Central South University
  • The Second Xiangya Hospital of Central South University
  • Zhuzhou Central Hospital
  • The First Affiliated Hospital of Baotou Medical College
  • Department of Rheumatology, The First People's Hospital of Changzhou
  • Nanjing Drum Tower Hospital
  • Jiangsu Province Hospital
  • Affiliated Hospital of Nantong University
  • Department of Rheumatology ,The First Affiliated Hospital of Soochow University
  • Department of Rheumatology, Northern Jiangsu People's Hospital
  • Jiu Jiang No.1 People's Hospital
  • Pingxiang People's Hospital
  • The First hospital of Jilin University
  • Linyi People's Hospital
  • Zhongshan Hospital Fudan University
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Department of Rheumatology and Immunology,West China Hospital，Sichuan University
  • Tianjin Medical University General Hospital, Rheumatology and Immunology Department
  • First Affiliated Hospital of Kunming Medical University
  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
  • The First Affiliated Hospital of Wenzhou Medical University
  • Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University
  • Huashan Hospital, Fudan University
  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Sequence A

Treatment Sequence B

Arm Description

Tofacitinib 5 mg BID for 6 months

Placebo for 3 months then tofacitinib 5 mg BID for 3 months

Outcomes

Primary Outcome Measures

Number of Participants With an American College of Rheumatology 50% (ACR50) Response
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP).

Secondary Outcome Measures

Number of Participants With an American College of Rheumatology 50% (ACR50) Response
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP).
Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP).
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP) at each visit.
Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
PsARC is comprised of 4 clinical improvement criteria: 1 unit (0-5 Likert scale) improvement on the Physician Global Assessment (PGA); 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in the number of tender joints; and 30% reduction in the number of swollen joints. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 scores could worsen.
Physician Global Assessment (PGA) of Psoriasis Score
PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.
Psoriasis Area and Severity Index (PASI)
PASI score ranges from 0 to 72, with higher scores representing greater severity of psoriasis
Dactylitis severity score
Dactyltis score based upon digit tenderness for each digit of hands and feet ranges from 0-60
Enthesitis score based upon Leeds Enthesitis Index (LEI)
Enthesitis score based upon presence/absence of enthesitis at 6 sites (LEI)
36-Item Short-Form Health Survey (SF-36)
The SF 36 v.2 (Acute) is a 36 item generic health status measure. It measures 8 general health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains can also be summarized as physical and mental component summary scores.
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
The EuroQol EQ 5D Health State Profile is a copyrighted, patient completed instrument designed to assess impact on health related quality of life in five domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Additionally, scores from the five domains may be used to calculate a single index value, also known as a utility score. The validity and reliability of the EuroQol EQ 5D has been established in a number of disease states, including PsA and rheumatoid arthritis.
Health Assessment Questionnaire Disability Index (HAQ DI)
The HAQ DI assesses the degree of difficulty a subject has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status.

Full Information

First Posted
March 5, 2018
Last Updated
August 25, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03486457
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
April 28, 2021 (Actual)
Study Completion Date
April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
psoriatic arthritis, tofacitinib, China

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Sequence A
Arm Type
Experimental
Arm Description
Tofacitinib 5 mg BID for 6 months
Arm Title
Treatment Sequence B
Arm Type
Placebo Comparator
Arm Description
Placebo for 3 months then tofacitinib 5 mg BID for 3 months
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Intervention Description
tablets, 5 mg BID x 6 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
tablets, to match tofacitinib 5 mg BID x 3 months
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Intervention Description
tablets, 5 mg BID x 3 months
Primary Outcome Measure Information:
Title
Number of Participants With an American College of Rheumatology 50% (ACR50) Response
Description
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP).
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Number of Participants With an American College of Rheumatology 50% (ACR50) Response
Description
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP).
Time Frame
Week 2, Month 1, Month 4, Month 6
Title
Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Description
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP).
Time Frame
Week 2, Month 1, Month 2, Month 3, Month 4, Month 6
Title
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Description
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP) at each visit.
Time Frame
Week 2, Month1, Month 2, Month 3, Month 4, Month 6
Title
Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
Description
PsARC is comprised of 4 clinical improvement criteria: 1 unit (0-5 Likert scale) improvement on the Physician Global Assessment (PGA); 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in the number of tender joints; and 30% reduction in the number of swollen joints. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 scores could worsen.
Time Frame
Month 1, Month 3, Month 6
Title
Physician Global Assessment (PGA) of Psoriasis Score
Description
PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.
Time Frame
Month 1, Month 3, Month 6
Title
Psoriasis Area and Severity Index (PASI)
Description
PASI score ranges from 0 to 72, with higher scores representing greater severity of psoriasis
Time Frame
Month 1, Month 3, Month 6
Title
Dactylitis severity score
Description
Dactyltis score based upon digit tenderness for each digit of hands and feet ranges from 0-60
Time Frame
Month 1, Month 3, Month 6
Title
Enthesitis score based upon Leeds Enthesitis Index (LEI)
Description
Enthesitis score based upon presence/absence of enthesitis at 6 sites (LEI)
Time Frame
Month 1, Month 3, Month 6
Title
36-Item Short-Form Health Survey (SF-36)
Description
The SF 36 v.2 (Acute) is a 36 item generic health status measure. It measures 8 general health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains can also be summarized as physical and mental component summary scores.
Time Frame
Month 1, Month 3, Month 6
Title
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Description
The EuroQol EQ 5D Health State Profile is a copyrighted, patient completed instrument designed to assess impact on health related quality of life in five domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Additionally, scores from the five domains may be used to calculate a single index value, also known as a utility score. The validity and reliability of the EuroQol EQ 5D has been established in a number of disease states, including PsA and rheumatoid arthritis.
Time Frame
Month 1, Month 3, Month 6
Title
Health Assessment Questionnaire Disability Index (HAQ DI)
Description
The HAQ DI assesses the degree of difficulty a subject has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status.
Time Frame
Week 2, Month 1, Month 2, Month 3, Month 4, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University/Rheumatology Department
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The First Affiliated Hospital of Army Medical University, PLA
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
Guangdong Second Provincial General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510317
Country
China
Facility Name
The Third Hospital of Hebei Medical University, Rheumatology and Immunology Department
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Zhuzhou Central Hospital
City
Zhuzhou
State/Province
Hunan
ZIP/Postal Code
412007
Country
China
Facility Name
The First Affiliated Hospital of Baotou Medical College
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
Department of Rheumatology, The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Facility Name
Department of Rheumatology ,The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Department of Rheumatology, Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
Jiu Jiang No.1 People's Hospital
City
Jiujiang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Facility Name
Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Facility Name
The First hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276003
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Department of Rheumatology and Immunology,West China Hospital，Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University General Hospital, Rheumatology and Immunology Department
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Rheumatology and Immunology Department, Xuanwu Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
City
Shanghai
ZIP/Postal Code
200052
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=A3921234
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

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