Efficacy and Safety of Interleukin-17 Inhibitor in Combination With Tumor Necrosis Factor α Inhibitor in the Treatment of Ankylosing Spondylitis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assessment of SpondyloArthritis International Society 40 (ASAS 40)
研究概览
简要总结
The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.
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
- •Male or female at least 18 years old;
- •diagnosed with AS according to the 1984 New York Modified Criteria;
- •Poor response after at least 2 NSAIDs (cumulative treatment ≥ 4 weeks), or contraindication or intolerance to NSAIDs therapy;
- •BASDAI score of ≥ 4 and total back pain VAS score of ≥ 4 at baseline;
- •Subjects who need to take NSAIDs (including COX-1 or COX-2 inhibitors) as established treatment for AS, and the NSAIDs should be on a stable dose for at least 2 weeks (inclusive) before screening and the dose is expected to be stable during the study;
- •Voluntary treatment with adalimumab and secukinumab;
- •Appropriate contraceptive measures for women of childbearing age;
- •without other rheumatic diseases.
- •Able to understand study requirements, provide written informed consent, and comply with trial protocol procedures (including required visits)
排除标准
- •With unstable vital signs, coma, mental and cognitive impairment;
- •Patients with severe systemic diseases and other serious chronic diseases;
- •Pregnant or lactating patients;
- •History of malignant tumor in the past 5 years;
- •Positive test for the following infection markers: human immunodeficiency virus (HIV), hepatitis B, hepatitis C, syphilis antibody;
- •Patients with active or recurrent history of infection; With active tuberculosis or have a history of active tuberculosis in the past;
- •Moderate to severe heart failure (New York Heart Association grade 3-4);
- •Allergic to any of the components of adalimumab (HS016) or secukinumab;
- •Subjects who are participating in clinical research of other drugs;
- •In addition to the above, the investigator judged that there are other reasons that are not suitable for participating in this clinical study.
研究组 & 干预措施
treatment group
The subjects were treated with adalimumab (HS016) in combination with secukinumab
干预措施: Secukinumab (Drug)
treatment group
The subjects were treated with adalimumab (HS016) in combination with secukinumab
干预措施: Adalimumab (Drug)
结局指标
主要结局
Assessment of SpondyloArthritis International Society 40 (ASAS 40)
时间窗: week 52
Proportion of subjects achieving ASAS 40 at Week 52. ASAS 40 is a response criterion used to evaluate the effectiveness of treatments in patients with ankylosing spondylitis. It measures the percentage of patients who achieve at least a 40% improvement in disease activity. Key Components of ASAS40: * Patient Global Assessment:Patient's overall assessment of disease activity * Pain: Assessment of spinal pain. * Function: Measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). * Inflammation: Based on morning stiffness severity and duration. Calculation: A patient is considered an ASAS40 responder if they achieve at least a 40% improvement or an absolute improvement of ≥2 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain.
Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)
时间窗: week 104
The mSASSS is a method used to assess spinal damage and function in patients with ankylosing spondylitis. The assessment Items includes: * Vertebral Scoring: It evaluates the morphology of each vertebra from T1 to L5. Each vertebra is scored from 0 to 3 based on the presence and degree of squaring, erosions, and syndesmophytes. For example, 0 means normal vertebra, and 3 indicates severe structural changes. * Intervertebral Disc Scoring: The intervertebral discs between the vertebrae are also assessed. The score ranges from 0 to 2, depending on the presence and extent of disc space narrowing and bridging syndesmophytes. Total Score Calculation: The scores of all vertebrae and intervertebral discs are summed up to obtain the mSASSS total score. The higher the score, the more severe the spinal damage.
ASAS40
时间窗: week 104
1. Proportion of subjects achieving ASAS 40 at Week 104. ASAS 40 is a response criterion used to evaluate the effectiveness of treatments in patients with ankylosing spondylitis. It measures the percentage of patients who achieve at least a 40% improvement in disease activity. Key Components of ASAS40: * Patient Global Assessment:Patient's overall assessment of disease activity * Pain: Assessment of spinal pain. * Function: Measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). * Inflammation: Based on morning stiffness severity and duration. Calculation: A patient is considered an ASAS40 responder if they achieve at least a 40% improvement or an absolute improvement of ≥2 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain.
Spondyloarthritis Research Consortium of Canada (SPARCC)
时间窗: week 104
The SPARCC assessment method is a valuable tool in the field of spondyloarthritis research and diagnosis. The assessment Items include: * Sacroiliac Joint Assessment: It evaluates the sacroiliac joints using magnetic resonance imaging (MRI). The assessment includes aspects such as bone marrow edema, erosion, and fatty infiltration in the sacroiliac joints. Each feature is scored based on its severity and extent. * Spinal Assessment: For the spine, SPARCC also uses MRI to assess inflammation. It focuses on detecting signs like vertebral corner inflammation (enthesitis) and discitis. Similar to the sacroiliac joint assessment, specific features are scored according to their characteristics. Scoring System: The total SPARCC score is obtained by summing up the scores of different items. Higher scores indicate more severe inflammation and greater disease activity.
次要结局
- BASDAI(week 12, week 24, week 52)
- tender joint count (TJC), swollen joint count(SJC)(week 12, week 24, week 52)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(week 12, week 24, week 52)
- Visual Analogue Scale (VAS)(week 12, week 24, week 52)
- Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)(week 12, week 24, week 52)
- Assessment in Ankylosing Spondylitis international Society Partial Release (ASAS PR)(week 12, week 24, week 52)
- Ankylosing Spondylitis Disease Activity Score based on C-reactive Protein (ASDAS-CRP)(week 12, week 24, week 52)
- Assessment of SpondyloArthritis International Society 20 (ASAS20)(week 12, week 24, week 52)
- Assessment of SpondyloArthritis International Society 5/6 (ASAS5/6)(week 12, week 24, week 52)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50(week 12, week 24, week 52)
- Ankylosing Spondylitis Disease Activity Score based on Erythrocyte Sedimentation Rate (ASDAS-ESR)(week 12, week 24, week 52)
- Ankylosing Spondylitis Quality of Life (ASQoL)(week 12, week 24, week 52)
- Adverse event (AE)(week 12, week 24, week 52，week 104)