A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 773
- 试验地点
- 126
- 主要终点
- Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment)
研究概览
简要总结
The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.
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
- Triple (Participant, Care Provider, 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
- •Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798), or RHBX (NCT02757352).
- •(Note: Participants from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor).
- •Must agree to use a reliable method of birth control.
排除标准
- •Have significant uncontrolled disorders or abnormal laboratory values that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered.
- •Have a known hypersensitivity to ixekizumab or any component of this investigational product.
- •Had investigational product permanently discontinued during a previous ixekizumab study.
- •Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the participant's participation in the study.
- •Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol.
- •Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
研究组 & 干预措施
Ixekizumab (IXE) 80Q4W
Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W).
干预措施: Ixekizumab (Drug)
Ixekizumab (IXE) 80Q2W
Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every two weeks (Q2W).
干预措施: Ixekizumab (Drug)
Placebo
Participants received subcutaneous dose of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment)
时间窗: Week 64
A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS \>3.5 at any visit during Period 2. ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
次要结局
- Percentage of Participants Who do Not Experience a Flare(Week 64)
- Percentage of Participants With No New Syndesmophyte Formation(Week 56)
- Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)(Baseline, 2 Years)
- Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response(Week 64)
- Change From Baseline in Chest Expansion in Centimeters(Baseline, Week 64)
- Change From Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16)(Baseline, Week 64)
- Percentage of Participants Achieving an ASAS40 Response(Week 64)
- Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score(Baseline, Week 64)
- Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints(Baseline, Week 64)
- Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units(Week 64)
- Change From Baseline in the Individual Components of the ASAS Criteria(Baseline, Week 64)
- Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units)(Week 64)
- Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)(Baseline, Week 64)
- Percentage of Participants With Anterior Uveitis or Uveitis Flares(Week 64)
- Change From Baseline in ASAS Health Index (ASAS HI)(Baseline, Week 64)
- Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response(Week 64)
- Change From Baseline in Occiput to Wall Distance(Baseline, Week 64)
- Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints(Baseline, Week 64)
- Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)(Baseline, Week 64)
- Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)(Baseline, Week 64)
- Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score(Baseline, Week 64)
- Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores(Baseline, Week 64)
- Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)(Baseline, Week 64)
- Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score(Baseline, Week 64)
- Change From Baseline in SF-36 Mental Component Summary (MCS) Score(Baseline, Week 64)
- Change From Baseline in the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) UK Population-based Index Score(Baseline, Week 64)
- Percentage of Participants With Anti-Ixekizumab Antibodies(Baseline, Week 64)