Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease
报名条件（概要）
- 年龄：18 Years – 65 Years
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
其他名称：Stelara
The initial intravenous (IV) infusion with ustekinumab at baseline was weight-adjusted (260 mg ≤55 kg, 390 mg between 55 and 85 kg, 520 mg ≥85 kg). According to the label, the first subcutaneous (SC) 90 mg induction dose was administered at week 8 followed by a maintenance dose of 90 mg SC every 8 or 12 weeks, at the discretion of the physician. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
Ustekinumab
Janssen Biotech, Inc.
合作机构
- Sixth Affiliated Hospital, Sun Yat-sen University研究机构/其他
- Second Affiliated Hospital of Soochow University研究机构/其他
- Chongqing Renji Hospital, University of Chinese Academy of SciencesOTHER_GOV
- The First Affiliated Hospital of Zhejiang Chinese Medical University研究机构/其他
- Seventh Medical Center of PLA Army General Hospital研究机构/其他
- First People's Hospital of Hangzhou研究机构/其他
- Yangzhou University研究机构/其他
- Xian-Janssen Pharmaceutical Ltd.企业
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
- Yan Chen, MD.chenyan72_72@zju.edu.cn+86-571-87783777
- Jingwen Liu, MD.jingwen@zju.edu.cn+86-571-87767061
中国／港澳台研究中心
- Department of Gastroenterology, Seventh Medical Center of PLA Army General HospitalBeijing，Beijing Municipality，China
- Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of SciencesChongqing，Chongqing Municipality，China
- Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen UniversityGuangzhou，Guangdong，China
- Department of Gastroenterology, Huai'an First People's HospitalHuai'an，Jiangsu，China
- Department of Gastroenterology, Second Affiliated Hospital of Soochow UniversitySuzhou，Jiangsu，China
- Department of Gastroenterology, Affiliated Hospital of Yangzhou UniversityYangzhou，Jiangsu，China
问自己是否符合条件、如何预筛
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease ClinicalTrials.gov Identifier: NCT05387031 Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine Investigational product: Ustekinumab About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease 试验编号：NCT05387031 申办方：Second Affiliated Hospital, Zhejiang University, School of Medicine 研究药物：Ustekinumab 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
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