A 52-Week Multicenter, Randomized, Open-Label, Parallel- Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 566
- 试验地点
- 131
- 主要终点
- Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)
研究概览
简要总结
The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.
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
- Single (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
- •Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
- •Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints
- •Presence of active plaque psoriasis with a BSA ≥3%
- •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
- •Have had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)
排除标准
- •Current or prior use of biologic agents for treatment of Ps or PsA
- •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
- •Active Crohn's disease or active ulcerative colitis
- •Active vasculitis or uveitis
- •Diagnosis of or history of malignant disease <5 years prior to randomization
- •Women who are breastfeeding
研究组 & 干预措施
Ixekizumab
160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline for all participants.
80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps.
80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.
干预措施: Ixekizumab (Drug)
Adalimumab
80 mg adalimumab given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps.
40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)
时间窗: Week 24
ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)\& swollen joint count (SJC)\& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% \& PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 \& BSA=0 at week 24.
次要结局
- Percentage of Participants Achieving PASI100(Week 24)
- Percentage of Participants Achieving ACR50(Week 24)