NCT01877668已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 422
- 试验地点
- 123
- 主要终点
- Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
研究概览
简要总结
This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.
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
- •Males or females, aged >= 18 years at time of consent.
- •Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
- •Meet the Classification Criteria of PsA (CASPAR) at time of screening
- •Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
- •Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
- •Must not have taken a biologic Tumour Necrosis Factor Inhibitor
- •Must have 3 or more swollen joints AND 3 or more tender joints
- •Must have active psoriasis skin lesions
排除标准
- •Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
- •Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
- •New York Heart Association Class III and IV congestive heart failure
- •History of hypersensitivity or infusion reaction to biologic agents
- •Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection
研究组 & 干预措施
Tofacitinib 5 mgBID x 12 months
Experimental
干预措施: Tofacitinib 5 mg BID (Drug)
Tofacitinib 10 mg BID x 12 months
Experimental
干预措施: Tofacitinib 10 mg BID (Drug)
Adalimumab 40 mg q2 weeks x 12 months
Active Comparator
干预措施: Adalimumab (Drug)
Placebo x3 months, then tofacitinib 5 mg BIDx 9 months
Placebo Comparator
干预措施: Placebo (Drug)
Placebo x 3 months, then tofacitinib 10 mg BID x 9 months
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
时间窗: From Baseline to Month 3
The HAQ-DI assesses the difficulty a participant has had in 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, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.
Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3
时间窗: At end of Month 3
ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).
次要结局
- Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12(At Week 2 and Months 1, 2, 4, 6, 9, and 12)
- Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis(From Baseline to Month 12)
- Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12(At Month 12)
- Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels(From Baseline to end of Month 3)
- Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain(From Baseline to end of Month 3)
- Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score(From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12)
- Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis(From Baseline to end of Month 3)
- Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis(From Baseline to end of Month 3)
- Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count(From Baseline to end of Month 3)
- Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response(From Baseline to Months 1, 3, 6, 9, and 12)
- Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12(At Months 1, 3, 6, 9, and 12)
- Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count(From Baseline to end of Month 3)
- Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain(From Baseline to Months 1, 3, 6, 9, and 12)
- Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12(At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12)
- Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12(At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12)
- Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in the Leeds Enthesitis Index (LEI)(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today(From Baseline to Months 1, 3, 6, 9, and 12)
- Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12(At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12)
- Change From Baseline in Dactylitis Severity Score (DSS)(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score(From Baseline to Months 1, 3, 6, 9, and 12)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score(From Baseline to Months 1, 3, 6, 9, and 12)
研究者
研究点 (123)
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