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临床试验/NCT01309737
NCT01309737已完成3 期

A Phase 3, Multi-Site, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Pfizer92 个研究点 分布在 2 个国家目标入组 960 人开始时间: 2011年3月最近更新:
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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
960
试验地点
92
主要终点
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.

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

  • •18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering at least 10% of body surface area
  • •A Psoriasis Area and Severity Index (PASI) score of 12 or greater
  • •Are considered to be candidates for systemic or light therapy
  • •Have no evidence of active or latent tuberculosis

排除标准

  • •Non-plaque or drug-induced forms of psoriasis
  • •Cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
  • •Any uncontrolled significant medical condition

研究组 & 干预措施

Active Treatment 10 mg BID

Experimental

干预措施: CP-690,550 (Drug)

Placebo Treatment

Placebo Comparator

干预措施: Placebo/CP-690,550 (Drug)

Active Treatment 5 mg BID

Experimental

干预措施: CP-690,550 (Drug)

结局指标

主要结局

Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16

时间窗: Week 16

The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.

Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16

时间窗: Week 16

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

次要结局

  • Dermatology Life Quality Index (DLQI) Total Score(Baseline)
  • Percent Probability of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 52(Week 52)
  • Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16(Baseline, Week 16)
  • Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 52(Week 52)
  • Percentage of Participants With Patient Satisfaction With Study Medication (PSSM) Score Response(Week 16, 28, 52)
  • Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16(Baseline, Week 16)
  • Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 4 and 16(Baseline, Week 4,16)
  • Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response(Baseline up to Week 16)
  • Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
  • Psoriasis Area and Severity Index (PASI) Component Scores(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
  • Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI 50) Response(Week 2, 4, 8,12,16, 20, 28, 40, 52)
  • Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 4(Week 4)
  • Psoriasis Area and Severity Index (PASI) Score(Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52)
  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52)
  • Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8, 12,16, 20, 28, 40, 52)
  • Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 16(Week 16)
  • Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 4(Week 4)
  • Percent Probability of Participants Maintaining Psoriasis Area and Severity Index 90 (PASI 90) Response at Week 52(Week 52)
  • Nail Psoriasis Severity Index (NAPSI) Score(Baseline, Week 8, 16, 20, 28, 40, 52)
  • Percentage of Participants With Nail Psoriasis Severity Index 75 (NAPSI 75) Response(Week 8, 16, 20, 28, 40, 52)
  • Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8,12, 16, 20, 28, 40, 52)
  • Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
  • Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52(Baseline,Week 8, 16, 20, 28, 40, 52)
  • Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'(Baseline up to Week 16)
  • Time to Achieve Psoriasis Area and Severity Index 50 (PASI 50) Response(Baseline up to Week 16)
  • Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Response(Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
  • Total Body Surface Area (BSA) With Psoriasis(Baseline, Week 2, 4, 8,16, 20, 28, 40, 52)
  • Percentage of Participants With Psoriasis Area and Severity Index (PASI) Score of at Least 125% of Baseline PASI Score(Week 2, 4, 8,12,16, 20, 28, 40, 52)
  • Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Week 8, 16, 20, 28, 40 and 52(Baseline,Week 8,16, 20, 28, 40, 52)
  • Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52)
  • Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI 90) Response(Week 2, 4, 8,12,16, 20, 28, 40, 52)
  • Percentage of Participants With Nail Psoriasis Severity Index 100 (NAPSI 100) Response(Week 8,16, 20, 28, 40, 52)
  • 36-Item Short-Form Health Survey Version 2, Acute (SF-36)(Baseline, Week 16, 28, 52)
  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Interaction With Healthcare Professional(Baseline, Week 16)
  • Number of Affected Nails(Baseline, Week 8, 16, 20, 28, 40, 52)
  • Itch Severity Item (ISI) Score(Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52)
  • Change From Baseline in Itch Severity Item (ISI) Score at Week 2, 4, 8, 12, 16, 20, 28, 40 and 52(Baseline, Week 2, 4, 8,12,16, 20, 28 , 40, 52)
  • Dermatology Life Quality Index (DLQI) Score(Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52)
  • Hospital Anxiety and Depression Scale (HADS) Score(Baseline, Week 8, 16, 28, 52)
  • Work Limitation Questionnaire (WLQ) Index Score(Baseline, Week 8, 16, 28, 52)
  • Percentage of Participants With Patient Global Assessment (PtGA) Scale Response(Baseline, Week 2, 4, 8,12,16, 20, 28, 40, 52)
  • Joint Pain Assessment (JPA) Score(Baseline, Week 8,16, 28, 52)
  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Healthcare Resource Use Events and Employment Status(Week 16)
  • Euro Quality of Life 5 Dimensions (EQ-5D) - Health State Profile Utility Score(Baseline, Week 16, 28, 40, 52)
  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Impact of Psoriasis on Work(Baseline, Week 16)
  • Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS)(Baseline,Week 16, 28, 40, 52)
  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Work Hours and Absent Hours(Baseline, Week 16)
  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Percent Absent Hours(Baseline, Week 16)
  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) - Psoriasis Affecting Ability to Work(Baseline, Week 16)
  • Family Dermatology Life Quality Index (FDLQI) Score(Baseline, Week 16, 52)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (92)

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