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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: Tofacitinib
* Other: Placebo
* Drug: Tofacitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence A<br>Tofacitinib 5 mg BID for 6 months | Drug: Tofacitinib<br>* tablets, 5 mg BID x 6 months<br>|
| Placebo Comparator: Treatment Sequence B<br>Placebo for 3 months then tofacitinib 5 mg BID for 3 months | Other: Placebo<br>* tablets, to match tofacitinib 5 mg BID x 3 months<br>Drug: Tofacitinib<br>* tablets, 5 mg BID x 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Week 2, Month 1, Month 4, Month 6 | 
| 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). | Week 2, Month 1, Month 2, Month 3, Month 4, Month 6 | 
| 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. | Week 2, Month1, Month 2, Month 3, Month 4, Month 6 | 
| 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. | Month 1, Month 3, Month 6 | 
| 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. | Month 1, Month 3, Month 6 | 
| Psoriasis Area and Severity Index (PASI) | PASI score ranges from 0 to 72, with higher scores representing greater severity of psoriasis | Month 1, Month 3, Month 6 | 
| Dactylitis severity score | Dactyltis score based upon digit tenderness for each digit of hands and feet ranges from 0-60 | Month 1, Month 3, Month 6 | 
| Enthesitis score based upon Leeds Enthesitis Index (LEI) | Enthesitis score based upon presence/absence of enthesitis at 6 sites (LEI) | Month 1, Month 3, Month 6 | 
| 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. | Month 1, Month 3, Month 6 | 
| 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. | Month 1, Month 3, Month 6 | 
| 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. | Week 2, Month 1, Month 2, Month 3, Month 4, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriatic arthritis, tofacitinib, China