A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing a Flare During Treatment Period 2
研究概览
简要总结
This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period) consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment Period 2
详细描述
TP1: All eligible subjects entered TP1 to receive 12-weeks of open-label secukinumab at a dose predicted to achieve secukinumab serum levels equivalent to adults administered a 150 mg dose regimen. Secukinumab was administered s.c. weekly for the first 4 weeks (Baseline, Weeks 1, 2, 3, 4) and then every 4 weeks thereafter. Clinical response (JIA ACR 30) was assessed at Week 12. Responders advanced to TP2 and non-responders exited the trial (early termination visit and entered into the Post-treatment follow-up period).
TP2: Subjects who were a responder (JIA ACR 30) at Week 12 entered the double-blind withdrawal TP2 and were randomized 1:1 to either secukinumab or placebo on that visit and then every 4 weeks, until either experiencing a disease flare or completion of TP2. TP2 was event driven and was planned to be closed when 33 subjects experienced a disease flare as per JIA definition. Alternatively, the study could be closed when all subjects reached the total study duration of 104 Weeks and therefore subjects who did not experience a disease flare remained in TP2 for the duration of the study and completed the study without entering into TP3
TP3: Subjects experiencing a disease flare in TP2 immediately entered TP3 to receive openlabel secukinumab every 4 weeks until total study duration of 104 weeks for that subject was achieved.
Post-treatment follow-up: The post-treatment follow-up period (lasting 12 weeks from the last study drug administration) was required for all subjects, unless they qualified and entered the secukinumab extension trial. All subjects were expected to participate in the post-treatment follow up period, except for those entering the extension study.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic arthritis (JPsA) according to the International League of Associations for Rheumatology (ILAR) classification criteria of at least 6 months duration.
- •Active disease (ERA or JPsA) defined as having both:
- •at least 3 active joints
- •at least 1 site of active enthesitis at baseline or documented by history.
- •Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs(NSAID)
- •Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD)
- •No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.
排除标准
- •Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.
- •Patients who have ever received biologic immunomodulating agents
- •Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only).
- •Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Treatment Period 2 - active
secukinumab (AIN457 - pre-filled syringe) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1
干预措施: secukinumab (Drug)
Treatment Period 2 - placebo
placebo comparator (matched to secukinumab treatment) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1
干预措施: placebo (Other)
结局指标
主要结局
Number of Participants Experiencing a Flare During Treatment Period 2
时间窗: From Week 12 until max Week 104
Survival analysis of time to flare in treatment period 2 (TP2) FAS2 Subjects are either ERA or JPsA
次要结局
- Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category(baseline, week 12)
- Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total(baseline, week 12)
- Percent Change From Baseline for JIA ACR Core Components in TP1(baseline, week 12)
- Percent Change in C-reactive Protein Standardized Value (mg/L)(baseline, week 12)
- Change From Baseline Juvenile Arthritis Disease Activity Score (JADAS) Score(12 weeks)
- Change From Baseline in Total Enthesitis Events - TP1 (FAS1)(Baseline and week 12)
- Change From Baseline in Total Dactylitis Count(baseline, week 12)
- Number of Participants With Anti-secukinumab Anitbodies(104 weeks)
- Secukinumab Serum Concentration(baseline, week 12)
- Number of Participants With Inactive Disease Status for All Subjects - TP1 (FAS1)(week 12)