A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 859
- 试验地点
- 172
- 主要终点
- Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)
研究概览
简要总结
The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).
详细描述
This was a Phase IIIb, multi-center, randomized, partially-blinded, active-controlled, parallel-group design in subjects with AS. The study consisted of a screening period (up to 10 weeks before randomization), a treatment period (104 weeks), and two follow-up visits (Weeks 112 and 120).
Subjects in both secukinumab dose groups received study treatment at baseline, Weeks 1, 2, 3 and 4 followed by treatment every 4 weeks through Week 100. Subjects in the GP2017 group received study treatment at baseline and every two weeks through Week 102. Subjects could self-administer all secukinumab / placebo and GP2017 doses at the study site or at home. Study treatment (secukinumab vs. GP2017) was provided in an open-label fashion. Subjects in the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). Subjects who received rescue treatment with prohibited medications were allowed to remain in the study but had to discontinue study treatment. Subjects were treated for 104 weeks with two follow-up visits (Weeks 112 and 120).
A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia.
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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
- Single (Outcomes Assessor)
盲法说明
The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose
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
- •Male or non-pregnant, non-nursing female patients at least 18 years of age
- •Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy
- •Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10
- •Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)
- •Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)
- •hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray
排除标准
- •Patients with total ankylosis of the spine
- •Pregnant or nursing (lactating) women
- •Evidence of ongoing infectious or malignant process
- •Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα
- •Subjects taking high potency opioid analgesics
- •Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)
时间窗: Baseline and at Week 104
Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score \<= 0.5.
次要结局
- Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)(Baseline and at Week 104)
- Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)(Baseline and at Week 104)
- Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)(Week 104)
- Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40)(Week 104)
- Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)(Baseline and at Week 104)
- Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)(Baseline and at Week 104)
- Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set)(Week 104)
- Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set)(Week 104)