MAXIMISE (Managing AXIal Manifestations in PsorIatic Arthritis With SEcukinumab), a Randomized, Double-blind, Placebo-controlled, Multicenter, 52-week Study to Assess the Efficacy and Safety of Secukinumab 150 mg or 300 mg s.c. in Participants With Active Psoriatic Arthritis and Axial Skeleton Involvement Who Have Inadequate Response to Non-steroidal Anti-inflammatory Drugs (NSAIDs)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Response to Treatment (300 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).
详细描述
In the anlalysis (CSR), there are 498 patients, as 5 patients were mis-randomized, i.e. had randomization number but did never take study medication. So there were 498 participants, and not 503
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
- •Written informed consent must be obtained before any assessment is performed
- •Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria
- •Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4
- •Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)
- •Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period
排除标准
- •History of exposure to other IL-17 or IL-23 inhibitor biologic drug
- •History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)
- •Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate
- •Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
- •Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
- •Other protocol-defined inclusion and exclusion criteria may have applied.
研究组 & 干预措施
AIN457 150mg
Secukinumab dose amount 1 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 1 sc injection every 4 weeks for remaining 44 weeks
干预措施: Secukinumab (Biological)
AIN457 300mg
Secukinumab dose amount 2 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 2 sc injection every 4 weeks for remaining 44 weeks
干预措施: Secukinumab (Biological)
AIN457 Placebo
Placebo sc injection weekly for 4 weeks and at week 8, followed by Secukinumab 150 mg or 300 mg sc injection every 4 week for remaining 40 weeks.
干预措施: Secukinumab (Biological)
AIN457 Placebo
Placebo sc injection weekly for 4 weeks and at week 8, followed by Secukinumab 150 mg or 300 mg sc injection every 4 week for remaining 40 weeks.
干预措施: Secukinumab and Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Response to Treatment (300 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12
时间窗: at week 12
Purpose of this measure: was to demonstrate that secukinumab 150 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12 after superiority of 300 mg was established ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥10 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
次要结局
- Percentage of Participants With Response to Treatment (150 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12(at week 12)
- Percentage of Participants With Response to Treatment (150 mg/300 mg AIN457) as Assessed by the ASAS40 Criteria at Week 12(at week 12)
- Percentage of Participants With Response to Treatment as Assessed by BASDAI50 at Week 12(at week 12)
- Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Any Time(at baseline, at week 12)
- Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Night(at baseline, at week 12)
- Change From Baseline Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Score at Week 12(baseline and week 12)
- Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12(baseline and week 12)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) at Week 12(baseline and week 12)
- Change From Baseline in Spondyloarthritis International Society (ASAS) Health Index at Week 12(baseline and week 12)
- Percentage of Participants With Response to Treatment as Assessed by the ACR20 Criteria at Week 12(at week 12)