NCT01695239已完成3 期
A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 417
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])
研究概览
简要总结
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
- •Active psoriatic arthritis (PsA) defined as the presence of at least 3 tender and at least 3 swollen joints
- •Presence of active psoriatic skin lesion or a personal history of plaque psoriasis (Ps)
- •Men must agree to use a reliable method of birth control or remain abstinent during the study
- •Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
排除标准
- •Current or prior use of biologic agents for treatment of Ps or PsA
- •Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs)
- •Current use of more than one conventional DMARD
- •Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
- •Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
- •Serious disorder or illness other than psoriatic arthritis
- •Serious infection within the last 3 months
- •Breastfeeding or nursing (lactating) women
研究组 & 干预措施
Ixekizumab Q2W
Experimental
Administered by 80 milligram (mg) subcutaneous (SC) injection every 2 weeks (Q2W).
干预措施: Ixekizumab (Drug)
Ixekizumab Q4W
Experimental
Administered by 80 mg SC injection every 4 weeks (Q4W).
干预措施: Ixekizumab (Drug)
Placebo
Placebo Comparator
Placebo for ixekizumab and placebo for adalimumab administered by SC injection.
干预措施: Placebo (Drug)
Adalimumab Q2W
Active Comparator
Administered by 40 mg SC injection Q2W.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])
时间窗: Week 24
ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).
次要结局
- Percentage of Participants Achieving ACR20 Response(Week 12)
- Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])(Baseline, Week 24)
- Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline(Week 24)
- Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline(Baseline, Week 24)
- Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)(Baseline, Week 24)
- Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline, Week 24)
- Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response(Week 24)
- Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score(Week 24)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])(Baseline, Week 24)
- Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])(Baseline, Week 24)
- Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)(Week 24)
- Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])(Baseline, Week 12)
- Change From Baseline in Leeds Enthesitis Index (LEI)(Baseline, Week 24)
- Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)(Baseline, Week 24)
- Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])(Baseline, Week 24)
- Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])(Baseline, Week 24)
- Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease(Baseline, Week 24)
- Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)(Week 24)
- Percent Change From Baseline in Body Surface Area (BSA)(Baseline, Week 24)
- Change From Baseline in Patient's Assessment of Pain VAS(Baseline, Week 24)
- Change From Baseline in Physician's Global Assessment of Disease Activity VAS(Baseline, 24 Weeks)
- Percent Change in American College of Rheumatology-N (ACR-N) Score(Baseline, 24 Weeks)
- Change From Baseline in Tender Joint Counts (TJC)(Baseline, Week 24)
- Change From Baseline in Swollen Joint Counts (SJC)(Baseline, Week 24)
- Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)(Baseline to Week 24)
- Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) VAS(Baseline, Week 24)
- Change From Baseline in C-Reactive Protein (CRP)(Baseline, Week 24)
- Change From Baseline in Itching Severity Using the Itch NRS(Baseline, Week 24)
研究者
研究点 (1)
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