注册号:
Registration number:
ChiCTR2500111171 最近更新日期:
Date of Last Refreshed on:
2025-10-27 17:00:47 注册时间:
Date of Registration:
2025-10-27 00:00:00 注册号状态:
预注册Registration Status:
Prospective registration注册题目:
真实世界中IL-1抑制剂治疗急性痛风性关节炎的有效性与安全性的单中心观察性研究Public title:
A Single-Center Observational Study on the Efficacy and Safety of IL-1 Inhibitors in Treating Acute Gouty Arthritis in the Real World注册题目简写:English Acronym:研究课题的正式科学名称:
真实世界中IL-1抑制剂治疗急性痛风性关节炎的有效性与安全性的单中心观察性研究Scientific title:
A Single-Center Observational Study on the Efficacy and Safety of IL-1 Inhibitors in Treating Acute Gouty Arthritis in the Real World研究课题代号(代码):
Study subject ID:在二级注册机构或其它机构的注册号:
The registration number of the Partner Registry or other
register:申请注册联系人:
赵娜
研究负责人:
孙雪辉 Applicant:
Zhao Na
Study leader:
Sun Xuehui 申请注册联系人电话:
Applicant telephone:
+86 15506571903
研究负责人电话:
Study leader's telephone:
+86 535 6290303申请注册联系人传真 :
Applicant Fax:
研究负责人传真:
Study leader's fax:申请注册联系人电子邮件:
Applicant E-mail:
zhaona1987615@163.com
研究负责人电子邮件:
Study leader's E-mail:
sxueh@sina.com申请单位网址(自愿提供):
Applicant website(voluntary supply):
研究负责人网址(自愿提供):
Study leader's website(voluntary supply):申请注册联系人通讯地址:
山东省烟台市芝罘区毓璜顶东路20号
研究负责人通讯地址:
山东省烟台市芝罘区毓璜顶东路20号Applicant address:
No.20, Yuhuangdingdong Road, Zhifu District,Yantai,Shandong Province, China
Study leader's address:
No.20, Yuhuangdingdong Road, Zhifu District,Yantai,Shandong Province, China申请注册联系人邮政编码:
Applicant postcode:
研究负责人邮政编码:
Study leader's postcode:申请人所在单位:
烟台毓璜顶医院Applicant's institution:
Yantai Yuhuangding Hospital研究负责人所在单位:
烟台毓璜顶医院Affiliation of the Leader:
Yantai Yuhuangding Hospital是否获伦理委员会批准:
是Approved by ethic committee:
Yes伦理委员会批件文号:
Approved No. of ethic committee:
YYYIRB-IIT[2025]089
伦理委员会批件附件:
Approved file of Ethical Committee:
查看附件View批准本研究的伦理委员会名称:
烟台毓璜顶医院临床研究伦理委员会Name of the ethic committee:
Yantai Yuhuangding Hospital Clinical Research Institutional Review Board伦理委员会批准日期:
Date of approved by ethic committee:
2025-09-23 00:00:00伦理委员会联系人:
李康琪Contact Name of the ethic committee:
Li Kangqi伦理委员会联系地址:
山东省烟台市芝罘区毓璜顶东路20号Contact Address of the ethic committee:
No.20, Yuhuangdingdong Road, Zhifu District,Yantai,Shandong Province, China伦理委员会联系人电话:
Contact phone of the ethic committee:
+86 535 6691999
伦理委员会联系人邮箱:
Contact email of the ethic committee:
likangqiyt@163.com研究实施负责(组长)单位:
烟台毓璜顶医院Primary sponsor:
Yantai Yuhuangding Hospital研究实施负责(组长)单位地址:
山东省烟台市芝罘区毓璜顶东路20号Primary sponsor's address:
No.20, Yuhuangdingdong Road, Zhifu District,Yantai,Shandong Province, China试验主办单位(项目批准或申办者):
Secondary sponsor:
国家:
中国
省(直辖市):
山东省
市(区县):
Country:
China
Province:
Shandong
City:
单位(医院):
烟台毓璜顶医院
具体地址:
山东省烟台市芝罘区毓璜顶东路20号
Institution
hospital:
Yantai Yuhuangding Hospital
Address:
No.20, Yuhuangdingdong Road, Zhifu District,Yantai,Shandong Province, China经费或物资来源:
自选课题(自筹)Source(s) of funding:
Self-funding研究疾病:
痛风 Target disease:
Gout研究疾病代码:Target disease code:研究类型:
观察性研究Study type:
Observational
study研究所处阶段:
上市后药物 Study phase:
4研究设计:
队列研究 Study design:
Cohort study 研究目的:
评估在真实世界中注射用伏欣奇拜单抗用于急性痛风性关节炎治疗的有效性和安全性。 Objectives of Study:
To evaluate the efficacy and safety of the injection of vusinhibab in the real world for the treatment of acute gouty arthritis.药物成份或治疗方案详述:
Description for medicine or protocol of treatment in
detail:
纳入标准:
1.能够自愿签署知情同意书,并且自愿配合按照方案完成试验者;
2.年龄≥10周岁,男女均可;
3.根据美国风湿病学会(ACR)2015年痛风分类标准诊断为痛风的患者;
4.距筛选前1年内有≥2次痛风急性发作;
5.当前的急性痛风发作在筛选期前5天内发生;
6.筛选期靶关节疼痛程度VAS≥50mm(VAS0-100mm),(VAS疼痛评分见附录二);
7.愿意在研究期间遵循方案的规定进行降尿酸治疗(ULT),满足以下条件之一: (1)正在接受ULT患者且稳定治疗≥14天,在参加试验期间需维持稳定的给药方案至少12周,除非经研究者评估原有降尿酸方案患者出现不耐受、或疗效不佳或尿酸达标,可以允许调整降尿酸治疗方案包括更换药物、减量或停药; (2)入组前没有使用ULT的患者,入组后14天内不允许采取降尿酸治疗,14天后由研究者根据尿酸水平决定是否采取降尿酸治疗; (3)入组前使用ULT但未稳定14天的患者,入组后14天内不允许采取降尿酸治疗,14天后由研究者根据尿酸水平决定是否采取降尿酸治疗。Inclusion criteria
1.Those who can voluntarily sign the informed consent form and are willing to cooperate with the completion of the trial as per the protocol;
2.Age >= 10 years old, both male and female are eligible;
3.Patients diagnosed with gout according to the 2015 American College of Rheumatology (ACR) classification criteria for gout;
4.Had >= 2 acute gout attacks within 1 year prior to screening;
5.The current acute gout attack occurred within 5 days before the screening period;
6.The pain degree of the target joint during the screening period was >= 50mm on the VAS scale (VAS 0-100mm) (See Appendix II for VAS pain score);
7.Willing to follow the protocol's regulations for uric acid-lowering treatment (ULT) during the study period, and meet one of the following conditions: (1) Patients currently receiving ULT and have been on stable treatment for ≥ 14 days. During the trial, the stable dosing regimen must be maintained for at least 12 weeks, unless the investigator assesses that the patient is intolerant to the original ULT regimen, or the treatment is ineffective, or the uric acid level has reached the target, in which case the ULT regimen can be adjusted, including changing the drug, reducing the dose, or discontinuing the treatment; (2) Patients who have not used ULT before enrollment are not allowed to take ULT within 14 days after enrollment. After 14 days, the investigator will decide whether to take ULT based on the uric acid level; (3) Patients who have used ULT but have not been on stable treatment for 14 days before enrollment are not allowed to take ULT within 14 days after enrollment. After 14 days, the investigator will decide whether to take ULT based on the uric acid level.排除标准:
1.接受过以下任何药物或治疗措施者: –在入组前4小时内使用了布洛芬、对乙酰氨基酚; –在入组前6小时内使用了双氯芬酸、曲马多,或应用了局部冰袋/冷冻包; –在入组前12小时内使用了塞来昔布、萘普生、洛索洛芬、洛芬待因或秋水仙碱; –在入组前24小时内使用了≥10mg强的松或相当剂量的激素; –在入组前24小时内使用了美洛昔康、依托考昔或其他短效止痛药物; –筛选前14天内使用了长效的阿片类药物治疗; –筛选前14天内采用关节腔内注射糖皮质激素治疗; –筛选前12周内累计超过28天或筛选前14天内连续接受≥5mg/d强的松(或当量的皮质类固醇)治疗; –筛选前30天内或3个半衰期内(以较长者为准,或者依据当地法规之规定)使用了任何IL-1阻断剂、TNF抑制剂、其他生物制剂; –筛选前1个月内持续使用经全身给药的免疫抑制剂治疗。
2.筛选前3天内存在需要采用全身用药控制的感染;
3.筛选前3个月内接种过活疫苗或减毒活疫苗,筛选前2周内接种新冠疫苗者,或计划在研究期间接种活疫苗或减毒活疫苗;
4.符合以下条件之一者:(1)确诊为活动性结核感染:包括但不限于影像学证实的活动性结核感染;(2)处于结核潜伏感染期或有感染结核病的高危因素可予以入组,但需排除研究者认为不适合入组的患者,如不愿意在进入试验后继续根据当地指南接受抗TB治疗者等;
5.筛选期实验室检查值存在以下异常: -白细胞计数或中性粒细胞绝对值低于研究中心检测正常值下限; -PLT≤100×10^9/L; -总胆红素>1.5×ULN、丙氨酸氨基转移酶(AST)>5×ULN、天冬氨酸氨基转移酶(ALT)>5×ULN;血清白蛋白<35g/L; -甘油三酯>5.7mmol/L;
6.筛选期血HCG阳性女性;哺乳期女性;
7.女性受试者不同意在从签署知情同意书至末次用药后6个月内,使用充分且有效的避孕措施者,除外绝经或子宫切除的受试者;
8.筛选前1个月内使用过研究性药物或参与过其它临床试验;
9.存在吸毒和/或精神障碍史;
10.经研究者判定,受试者存在不适合参加本临床试验的情况。Exclusion criteria:
1.Those who have received any of the following drugs or treatments within the specified time periods: - Ibuprofen or acetaminophen within 4 hours before enrollment; - Diclofenac, tramadol, or local ice packs/cold packs within 6 hours before enrollment; - Celecoxib, naproxen, lornoxicam, codeine, or colchicine within 12 hours before enrollment; - Prednisone ≥ 10 mg or equivalent doses of corticosteroids within 24 hours before enrollment; - Meloxicam, etoricoxib, or other short-acting analgesics within 24 hours before enrollment; - Long-acting opioid treatment within 14 days before screening; - Intra-articular injection of glucocorticoids within 14 days before screening; - Prednisone >= 5 mg/day or equivalent doses of corticosteroids for more than 28 days within 12 weeks before screening or for more than 14 consecutive days before screening; - Any IL-1 blocker, TNF inhibitor, or other biologics within 30 days before screening or within 3 half-lives (whichever is longer, or as per local regulations); - Systemic immunosuppressants within 1 month before screening.
2.Those with an infection requiring systemic treatment within 3 days before screening;
3.Those who have received live or attenuated live vaccines within 3 months before screening, or have received the COVID-19 vaccine within 2 weeks before screening, or plan to receive live or attenuated live vaccines during the study period;
4.Those who meet any of the following conditions: (1) Confirmed active tuberculosis infection, including but not limited to active tuberculosis infection confirmed by imaging; (2) Those in the latent tuberculosis infection stage or with high-risk factors for tuberculosis infection can be included, but patients deemed unsuitable for inclusion by the investigator, such as those unwilling to continue anti-TB treatment according to local guidelines after entering the trial, should be excluded;
5.Those with abnormal laboratory values during the screening period: - White blood cell count or absolute neutrophil count below the lower limit of normal at the research center; - PLT <= 100 × 10^9/L; - Total bilirubin > 1.5 × ULN, AST > 5 × ULN, ALT > 5 × ULN; serum albumin < 35 g/L; - Triglycerides > 5.7 mmol/L;
6.Women with positive blood HCG during the screening period; lactating women;
7.Female subjects who do not agree to use adequate and effective contraceptive measures from signing the informed consent form to 6 months after the last dose of study drug, except for those who are postmenopausal or have undergone hysterectomy;
8.Those who have used investigational drugs or participated in other clinical trials within 1 month before screening;
9.Those with a history of drug abuse and/or mental disorders;
10.Those who, in the opinion of the investigator, are not suitable for participation in this clinical trial.研究实施时间:
Study execute time:
从
From
2025-11-01 00:00:00至
To
2027-12-31 00:00:00
征募观察对象时间:
Recruiting time:
从
From
2025-11-01 00:00:00
至
To
2026-11-30 00:00:00干预措施:
Interventions:
组别:
暴露组
样本量:
20
Group:
Exposure group
Sample size:
干预措施:
无
干预措施代码:
Intervention:
None
Intervention code:研究实施地点:
Countries of recruitment and research settings:
国家:
中国
省(直辖市):
山东省
市(区县):
Country:
China
Province:
Shandong
City:
单位(医院):
烟台毓璜顶医院
单位级别:
三级甲等
Institution
hospital:
Yantai Yuhuangding Hospital
Level of the institution:
Tertiary A测量指标:
Outcomes:
指标中文名:
6个月痛风复发率
指标类型:
主要指标
Outcome:
The recurrence rate of gout within six months
Type:
Primary indicator
测量时间点:
6个月
测量方法:
计算首次治疗后6个月内至少有1次复发的患者比例;
Measure time point of outcome:
six months
Measure method:
Calculate the proportion of patients who had at least one recurrence within 6 months after the first treatment.
指标中文名:
72h靶关节的疼痛VAS评分(0-100mm)较基线的变化
指标类型:
次要指标
Outcome:
The change in the VAS score (0-100mm) of the target joint pain at 72 hours compared to the baseline.
Type:
Secondary indicator
测量时间点:
72h
测量方法:
VAS评分(0-100mm)
Measure time point of outcome:
72h
Measure method:
VAS score (0-100mm)
指标中文名:
不良事件
指标类型:
次要指标
Outcome:
Adverse event
Type:
Secondary indicator
测量时间点:
6个月
测量方法:
不良事件、临床安全性实验室检查、心电图、生命体征以及常规体格检查
Measure time point of outcome:
six months
Measure method:
Adverse events, clinical safety laboratory tests, electrocardiograms, vital signs and routine physical examinations采集人体标本:
Collecting sample(s)
from participants:
标本中文名:
无
组织:
Sample Name:
NA
Tissue:
人体标本去向
其它
说明
Fate of sample:
0thers
Note:征募研究对象情况:
Recruiting status:
尚未开始
Not yet
recruiting
年龄范围:
Participant age:
最小
Min age
10
岁
years
最大
Max age
岁
years性别:
男女均可
Gender:
Both随机方法(请说明由何人用什么方法产生随机序列):
无Randomization Procedure (please state who
generates the
random number sequence and by what method):
None是否公开试验完成后的统计结果:
Calculated Results after the Study Completed public access:
不公开/Private盲法:
无Blinding:
None是否共享原始数据:
IPD sharing
否No共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):
不适用The way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url):
Not applicable.数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case
Record Form, CRF),二为电子采集和管理系统(Electronic Data
Capture, EDC),如ResMan即为一种基于互联网的EDC:
病例记录表Data collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture:
Case Record Form, CRF数据与安全监察委员会:
Data and Safety Monitoring Committee:
无/No注册人:
Name of Registration:
2025-10-27 17:00:01