A Phase 3, Multicenter Study With a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period From Week 36 to Week 104 to Evaluate the Long-Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 22
- 主要终点
- Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA])
研究概览
简要总结
The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab 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
- Double (Participant, Investigator)
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 (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
- •Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
- •Presence of active psoriatic skin lesion or a 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
- •Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
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 cDMARDs
- •Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
- •Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
- •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 Open Label
Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).
干预措施: Ixekizumab (Drug)
Ixekizumab
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).
干预措施: Ixekizumab (Drug)
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
干预措施: Ixekizumab (Drug)
Placebo
Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period.
Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)
干预措施: Placebo (Drug)
IXE80Q2W Non-randomized
Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period.
Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.
干预措施: Ixekizumab (Drug)
结局指标
主要结局
Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA])
时间窗: Double Blind Randomization through Week 104 (or Early Termination or Relapse)
Relapse is loss of MDA response. MDA is achieved if 5 of 7 outcome measures are fulfilled:TJC ≤1;SJC ≤1;psoriasis activity \& severity index(PASI total score) ≤1 or body surface area(BSA) ≤3;participant pain VAS score of ≤15;participant global disease activity VAS score of ≤20;HAQ-DI score ≤0.5;and tender entheseal points ≤1.Participants met the randomization criteria if they had MDA for 3 consecutive months over 4 consecutive visits.Time-to relapse was calculated in weeks as follows:((Date of Relapse) - Date of first injection of randomized study treatment in period 3)+1) divided by 7.If the date of first dose is missing,the date of randomization will be used.Participants completing Period 3 will be censored at date of completion(the date of the last scheduled visit in the period).Participants without a date of completion or discontinuation for Period 3 will be censored at latest non-missing date out of the following dates:date of last dose \& date of last attended visit in Period 3.
次要结局
- Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA(Double Blind Randomization through Week 104 (or Early Termination or Relapse))
- Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC)(Double Blind Randomization through Week 104 (or Early Termination or Relapse))
- Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Patients Global Assessment of Disease Activity (PatGA) Visual Analog Scale (VAS) Score(Double Blind Randomization through Week 104 (or Early Termination or Relapse))
- Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC)(Double Blind Randomization through Week 104 (or Early Termination or Relapse))
- Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI)(Double Blind Randomization through Week 104 (or Early Termination or Relapse))
- Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA(Double Blind Randomization through Week 104 (or Early Termination or Relapse))
- Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Pain Visual Analog Scale (VAS) Score(Double Blind Randomization through Week 104 (or Early Termination or Relapse))
- Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Health Assessment Questionnaire-Disability Index (HAQ-DI)(Double Blind Randomization through Week 104 (or Early Termination or Relapse))
- Open-Label Treatment Period: Time to Achieve Randomization Criteria (Meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits)(Open Label Baseline through Double-Blind Randomization (Week 36 to 64))
- Double-Blind Withdrawal Period: Time to Re-Gain MDA Following Relapse in MDA(Relapse in MDA After Double Blind Randomization through Week 104 (or Early Termination))
- Double-Blind Withdrawal Period: Change From Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, 40 Weeks from Double Blind Randomization (Week 36 to 64))
- Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Entheseal Points(Double Blind Randomization through Week 104 (or Early Termination or Relapse))