An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of SpondyloArthritis International Society 20 Response (ASAS20)
研究概览
简要总结
The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the registration of secukinumab in Japan for the treatment of active AS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS with active AS assessed by BASDAI ≥ 4 (0-10) and spinal pain as measured by VAS≥ 4 cm (BASDAI question #2) at Baseline
- •Patients should have been on NSAIDs at the highest recommended dose for at least 3 months prior to baseline with an inadequate response or failure to respond, or less than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications
- •Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or have been intolerant to at least one administration of an anti-TNFα agent
排除标准
- •Patients with total ankylosis of the spine
- •Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
- •Active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis
- •Known infection with HIV, hepatitis B or hepatitis C at screening or baseline
研究组 & 干预措施
secukinumab 150mg
A screening (SCR) epoch running 4-10 weeks before baseline (BSL) was used to assess eligibility followed by 52 weeks of treatment. The treatment periods consist of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 follows a post-treatment follow-up until Week 60. A follow-up visit was done at 12 weeks after last study treatment administration for all patients, regardless of whether they completed the entire study as planned (Week 60) or discontinue prematurely.
干预措施: Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection. (Drug)
结局指标
主要结局
Assessment of SpondyloArthritis International Society 20 Response (ASAS20)
时间窗: week 16
This table is ASAS20 response using non-responder imputation for FAS It assesses the efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline in Japanese patients with active AS based on the proportion of patients achieving an ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response. The ASAS Response Criteria (ASAS 20) is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥ 20% and ≥ 1 unit on a scale of 10 in the remaining domain
次要结局
- ASAS 40 Response Rate With Non-responder Imputation (NRI)(Week 16)
- Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 Response Rate(Week 16)
- Change in High Sensitivity C-Reactive Protein (hsCRP)(baseline, Week 16)
- Number of Participants With ASAS 5/6 Response Criteria(Week 16)
- Mean Change From Baseline in BASDAI From Baseline(Baseline, week 16)
- Change From Baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) Score(Baseline, week 16)
- Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score(Baseline, week 16)
- Proportion of Participants Achieving ASAS Partial Remission(week 16)
- Change in Serum Concentration of Secukinumab(Baseline, weeks 4, 16, 24, 52, 60)
- Number of Participants With Immunogenicity Against Secukinumab(week 60)
- Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood(week 60)
- Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade(week 60)
- Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities(week 60)
- Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities(week 60)
- Participants With Newly Occurring Notable Abnormalities in Vital Signs(week 60)