A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 219
- 试验地点
- 48
- 主要终点
- Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16
研究概览
简要总结
This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints.
- •Active plaque psoriasis at screening and baseline.
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
PF-06700841 60 mg once daily
PF-06700841 60 mg once daily for 52 weeks
干预措施: PF-06700841 (Drug)
PF-06700841 30 mg once daily
PF-06700841 30 mg once daily for 52 weeks
干预措施: PF-06700841 (Drug)
PF-06700841 10 mg once daily followed by 60 mg once daily
PF-06700841 10 mg once daily for 16 weeks, followed by 60 mg once daily until Week 52
干预措施: PF-06700841 (Drug)
PF-06700841 10 mg once daily followed by 30 mg once daily
PF-06700841 10 mg once daily for 16 weeks, followed by 30 mg once daily until Week 52
干预措施: PF-06700841 (Drug)
Placebo once daily followed by 60 mg once daily
Placebo once daily for 16 weeks, followed by PF-06700841 60 mg once daily until Week 52
干预措施: Placebo (Other)
Placebo once daily followed by 30 mg once daily
Placebo once daily for 16 weeks, followed by PF-06700841 30 mg once daily until Week 52
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants Achieving an American College of Rheumatology 20 (ACR20) Response at Week 16
时间窗: Week 16
ACR 20 was calculated as a ≥20% improvement in tender and swollen joint counts and ≥20% improvement in 3 of the 5 remaining ACR core set measures: patient pain assessment (a horizontal visual analog scale assessment of the patient's level of pain), patient global assessment (the patient's overall assessment of how the arthritis was doing by a visual analog scale), physician global assessment (a horizontal visual analog scale measure of the physician's assessment of the patient's current disease activity), patient self-assessed disability (a validated and reliable patient self-assessment instrument which measured physical functions in rheumatoid arthritis patients) and an acute-phase reactant (C-reactive protein level). The participants receiving placebo in the initial period (Day 1 - Week 16) were combined into a single placebo group, while those who received PF-06700841 (10 mg QD) in the initial period were combined into a single PF-06700841 10 mg QD group.
次要结局
- Percentage of Participants Achieving an ACR20 Response at Week 16 in the Subgroup of Participants Who Were Tumor Necrosis Factor (TNF) α Inhibitor naïve(Week 16)
- Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in Patient's Assessment of Arthritis Pain at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Percentage of Participants Achieving an ACR20 Response at Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52(Weeks 2, 4, 8, 12, 20, 28, 36, 44 and 52)
- Percentage of Participants Achieving an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in Tender/Painful Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in Physician's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index (DI) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in Patient's Global Assessment of Arthritis at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Percentage of Participants Achieving a PASI 90 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Percentage of Participants Achieving a PASI 100 Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in the Enthesitis Score (Using the Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in the Enthesitis Score (Using the Leeds Enthesitis Index) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in the Dactylitis Severity Score (DSS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in the Patient's Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 2, 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in the Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Percentage of Participants Achieving the Psoriatic Arthritis Response Criteria (PsARC) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52(Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (All Causalities)(Baseline (Day 1) through Week 56)
- Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline (Day 1) Through Week 56 (Treatment-related)(Baseline (Day 1) through Week 56)
- Change From Baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52(Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Percentage of Participants Achieving Minimal Disease Activity (MDA) at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52(Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Percentage of Participants Achieving Very Low Disease Activity (VLDA) Response at Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52(Weeks 4, 8, 12, 16, 20, 28, 36, 44 and 52)
- Number of Participants Who Discontinued From Study Due to Treatment-emergent AEs From Baseline (Day 1) Through Week 56(Baseline (Day 1) through Week 56)