NCT03486457已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 204
- 试验地点
- 38
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment Sequence B
Placebo Comparator
Placebo for 3 months then tofacitinib 5 mg BID for 3 months
干预措施: Placebo (Other)
Treatment Sequence A
Experimental
Tofacitinib 5 mg BID for 6 months
干预措施: Tofacitinib (Drug)
Treatment Sequence B
Placebo Comparator
Placebo for 3 months then tofacitinib 5 mg BID for 3 months
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3
时间窗: 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).
次要结局
- 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 ACR50 Response at Week 2, Month 1, 2, 4, and 6(Week 2, Month 1, 2, 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)
- 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)
- Change From Baseline in Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS) at Week 2, Month 1, 2, 3, 4, and 6(Baseline, Week 2, Month 1, 2, 3, 4, and 6)
- Physician's Global Assessment of Psoriasis (PGA-PsO) Response Rates for Participants With Baseline PGA-PsO ≥2 at Month 1, 3 and 6(Month 1, 3 and 6)
- 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(Week 2, Month 1, 2, 3, 4, and 6)
- Change From Baseline in Swollen Joint Count at Week 2, Month 1, 2, 3, 4, and 6(Baseline, Week 2, Month 1, 2, 3, 4, and 6)
- Change From Baseline in Tender/Painful Joint Count at Week 2, Month 1, 2, 3, 4, and 6(Baseline, Week 2, Month 1, 2, 3, 4, and 6)
- Change From Baseline in Patient's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6(Baseline, Week 2, Month 1, 2, 3, 4, and 6)
- Change From Baseline in Physician's Global Assessment of Arthritis (VAS) at Week 2, Month 1, 2, 3, 4, and 6(Baseline, Week 2, Month 1, 2, 3, 4, and 6)
- Change From Baseline in CRP at Week 2, Month 1, 2, 3, 4, and 6(Baseline, Week 2, Month 1, 2, 3, 4, and 6)
- Change From Baseline in PGA-PsO for Participants With Baseline PGA-PsO>0 at Month 1, 3 and 6(Baseline, Month 1, 3 and 6)
- 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(Month 1, 3 and 6)
- Percent Change From Baseline in PASI Score at Month 1, 3 and 6 for Participants With Baseline BSA ≥3% and Baseline PASI >0(Baseline, Month 1, 3 and 6)
- 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(Baseline, Month 1, 3 and 6)
- Percent Change From Baseline in BSA at Month 1, 3 and 6 for Participants With Baseline BSA >0%(Baseline, Month 1, 3 and 6)
- Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Domain Scores at Month 1, 3 and 6(Baseline, Month 1, 3 and 6)
- Change From Baseline in Physician's Global Assessment of Psoriatic Arthritis (PGA-PsA) (VAS) at Month 1, 3 and 6(Baseline, Month 1, 3 and 6)
- Resolution Rate of Dactylitis at Month 1, 3 and 6 for Participants With Baseline Dactylitis Severity Score (DSS) >0(Month 1, 3 and 6)
- Change From Baseline in DSS for Participant With Baseline DSS >0 at Month 1, 3 and 6(Baseline, Month 1, 3 and 6)
- Change From Baseline in Disease Activity Score (DAS)28-3 (CRP) at Week 2, Month 1, 2, 3, 4, and 6(Baseline, Week 2, Month 1, 2, 3, 4, and 6)
- Resolution Rate of Enthesitis at Month 1, 3 and 6 for Participants With Baseline Leeds Enthesitis Index (LEI) >0(Month 1, 3 and 6)
- Change From Baseline in LEI for Participant With Baseline LEI >0 at Month 1, 3 and 6(Baseline, Month 1, 3 and 6)
- Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score at Month 1, 3 and 6(Baseline, Month 1, 3 and 6)
- 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(Baseline, Month 3 and 6)
- Change From Baseline in WPAI-PsA at Month 3 and 6: Activity Impairment(Baseline, Month 3 and 6)
- Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Month 1, 3 and 6 for Participants With Baseline NAPSI >0(Baseline, Month 1, 3 and 6)
- Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Week 2, Month 1, 2, 3, 4, and 6(Week 2, Month 1, 2, 3, 4, and 6)
- Change From Baseline in Short-Form-36 Health Survey (SF-36) Version 2, Acute at Month 1, 3 and 6(Baseline, Month 1, 3 and 6)
研究者
研究点 (38)
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