Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis: a Multicenter Randomized Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 5
- 主要终点
- Patient ASAS40 remission rate after 12 weeks of patient medication
研究概览
简要总结
The purpose of the study is to verify the clinical feasibility of Benzathine penicillin (BPG) /Etanercept (ETN) combination regimen in patients with spondyloarthritis (SpA) and at the same time compare Benzathine penicillin /Etanercept combination regimen and Etanercept maintenance therapy in reducing disease activity, improving patients' clinical symptoms and body function scores, enhancing quality of life, improving imaging performance and safety.
详细描述
This trial is a randomised, double-blinded, placebo-controlled, polycentric study. The study consisted of a screening period (up to 2 weeks before randomization), a treatment period (24 weeks), and 5 follow-up visits (Weeks 0, 6, 12,18 and 24).
After a 2-week preparation period, 340 patients with SpA will be randomly and equally assigned to either experimental group consisting of BPG (injection form, 1.2 million units of intramuscular injection, once every two weeks) with ETN (injection form, 25mg of hypodermic injection, twice a week) or the control group consisting of placebos (injection form, once every two weeks) with ETN (injection form, 25mg of hypodermic injection, twice a week),with treatment lasting for 12 weeks. After 12 weeks of treatment, the label will be opened, and all patients will choose to use BPG combined with ETN maintenance therapy for another 12 weeks of treatment. Follow-up will be conducted at baseline, 6 weeks,12 weeks,18 weeks and 24 weeks after the end of treatment. The primary outcome is the response rate of ASAS40 in patients after 12 weeks of medication. The secondary outcomes are the severity of symptoms, disease activity, quality of life, and imaging progression scale scores of patients at each follow-up point. We will synchronize the recording of adverse events to compare the safety of the two treatment regimens
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following patients would be included: (1) The subjects voluntarily participate and sign an informed consent form; (2) patients aged 18-59 years; (3) According to the following guidelines or diagnostic criteria, a standardized diagnosis of spinal arthritis patients is made, which meets one of the following diagnostic criteria: ① 2009 ASAS classification criteria for axial spinal arthritis; ② Classification criteria for ASAS peripheral spondyloarthritis in
- •And subjects with spinal arthritis who are in a relatively active period (ASDAS-CRP>1.2 )of infection;
排除标准
- •he exclusion criteria are as follows: (1) Subjects with nasopharyngitis, active tuberculosis, inflammatory bowel disease and other infections, other rheumatic and immune diseases, malignant tumors, and concomitant bone and joint diseases; (2) Individuals who are allergic to the components of the experimental drug; (3)Severe abnormalities in liver and kidney function (liver enzymes ≥ 2 times normal; creatinine ≥ 2 times normal); (4)Pregnant, preparing for pregnancy or breastfeeding women; (5)Moderate to severe heart failure (New York Heart Association grades 3-4); (6)Some researchers believe that other situations are not suitable for the use of etanercept or other experimental drugs; (7)Active gastrointestinal ulcer/bleeding; (8) According to the researcher's judgment, it is not suitable to participate in this study; (9)Patients in the acute phase of streptococcal infection: present with clinical manifestations of acute pharyngitis, acute tonsillitis, scarlet fever, and streptococcal pyoderma, and ASO or ADNS>normal range, and/or CRP>normal range.
研究组 & 干预措施
BPG with ETN
Blinded "BPG with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24.
干预措施: Etanercept (Biological)
BPG with ETN
Blinded "BPG with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24.
干预措施: Benzathine Penicillin (Drug)
Placebo with ETN
Blinded "Placebo with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24.
干预措施: Etanercept (Biological)
Placebo with ETN
Blinded "Placebo with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24.
干预措施: Benzathine Penicillin (Drug)
Placebo with ETN
Blinded "Placebo with ETN" from Week 0 to Week 12, open-label "BPG with ETN" from Week 12 to Week 24.
干预措施: Placebo (Other)
结局指标
主要结局
Patient ASAS40 remission rate after 12 weeks of patient medication
时间窗: Week 12
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity.
次要结局
- Improvement rate of Spondyloarthritis Research Consortium of Canada Score （SPARCC）(Baseline and Week 12、24)
- ASAS20 remission rate(Week 6、12、18、24)
- Improvement rate of Spondyloarthritis Research Consortium of Canada Sacroiliac Joint Structural Score（SPARCCSSS）(Baseline and Week 12、24)
- Change From Baseline in Patient Global Assessment(Baseline and Week 6、12、18、24)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index （BASDAI）Score(Baseline and Week 6、12、18、24)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score(Baseline and Week 6、12、18、24)
- C-reactive protein-based Ankylosing Spondylitis Disease Activity Score（ASDASCRP）(Baseline and Week 6、12、18、24)
- Change From Baseline in the scale of quality of life for ankylosing spondylitis (SQOL-AS)(Baseline and Week 6、12、18、24)
- Terms and Conditions for Using the 36-Item Short Form Survey（SF-36）（Physical Functioning (PF)、Mental Health (MH) ）(Baseline and Week 6、12、18、24)
- Bath Ankylosing Spondylitis Metrology Index (BASMI) Score(Baseline and Week 12、24)
- Change From Baseline in Maastricht ankylosing spondylitis enthesitis （MASES） score(Baseline and Week 12、24)
- Change From Baseline in Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) Questionnaire(Baseline and Week 6、12、18、24)
- Change From Baseline in Swollen Joint Count, Tender Joint Count(Baseline and Week 12、24)
- Change From Baseline in Indicators of streptococcal infection(Baseline and Week 6、12、18、24)
- Change From Baseline in Bath Ankylosing Spondylitis-Global （BAS-G） Score(Baseline and Week 6、12、18、24)