Ustekinumab 在儿科参与者中的长期扩展研究 (UNITED)
在儿科临床研究参与者（2 至
The purpose of this study is to collect long-term safety data of subcutaneous (SC) ustekinumab
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Beer Yaakov、以色列、70300
- Yitzhak Shamir Medical Center
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Jerusalem、以色列、9103102
- Shaare Zedek Medical Center
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Ramat Gan、以色列、5266202
- Sheba Medical Center
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Budapest、匈牙利、1083
- Semmelweis Egyetem
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Debrecen、匈牙利、4032
- Debreceni Egyetem Klinikai Kozpont
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Miskolc、匈牙利、3526
- Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
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Nyíregyháza、匈牙利、4400
- Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
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Szeged、匈牙利、6720
- Szegedi Tudomanyegyetem
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Ankara、土耳其（türkiye）、06230
- Hacettepe University Medical Faculty
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Istanbul、土耳其（türkiye）、34098
- Cerrahpasa Medical Faculty Hospital
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Aachen、德国、52074
- Universitaetsklinikum der RWTH Aachen
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Berlin、德国、13353
- Charite Universitatsmedizin Berlin Campus Virchow Klinikum
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Milan、意大利、20122
- Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
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Bunkyō City、日本、113 8431
- Juntendo University Hospital
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Gunma、日本、371-0034
- Gunma University Hospital
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Ikoma、日本、630 0293
- Kindai University Nara Hospital
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Kurume、日本、830-0011
- Kurume University Hospital
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Saitama Shi、日本、330-8777
- Saitama Childrens Medical Center
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Sendai、日本、989-3126
- Miyagi Childrens Hospital
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Setagaya Ku、日本、157 8535
- National Center for Child Health and Development
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Tsu、日本、514 8507
- Mie University Hospital
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Brussels、比利时、1200
- Cliniques Universitaires Saint Luc
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Brussels、比利时、1020
- Huderf
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Ghent、比利时、9000
- UZ Gent
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Jette、比利时、1090
- UZ Brussel
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Leuven、比利时、3000
- Uz Gasthuisberg
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Paris、法国、75015
- Hôpital Necker
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Krakow、波兰、30 663
- Uniwersytecki Szpital Dzieciecy w Krakowie
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Rzeszów、波兰、35-302
- Korczowski Bartosz Gabinet Lekarski
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Sosnowiec、波兰、41 200
- Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
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Torun、波兰、87 100
- GASTROMED Sp. z o.o.
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Warsaw、波兰、04 730
- Instytut Pomnik Centrum Zdrowia Dziecka
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Warsaw、波兰、04-501
- Medical Network
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Warsaw、波兰、04-501
- Medical Network 1
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Georgia
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Atlanta、Georgia、美国、30342
- Children's Center For Digestive Healthcare, Llc
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New York
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New York、New York、美国、10029
- Mount Sinai
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North Carolina
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Charlotte、North Carolina、美国、28207
- Levine Childrens at Atrium Health
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Virginia
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Fairfax、Virginia、美国、22031
- Pediatric Specialists Of Virginia
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Birmingham、英国、B4 6NH
- Birmingham Children's Hospital
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Cambridge、英国、Cb2 2qq
- Addenbrookes Hospital
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London、英国、E1 1BB
- Royal London Hospital
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London、英国、WC1N 3JH
- Great Ormond Street Hospital
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Sheffield、英国、S10 2TH
- Sheffield Children's Hospital
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Southampton、英国、SO16 6YD
- Southampton University Hospital
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Valencia、西班牙、46026
- Hosp. Univ. I Politecni La Fe
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Buenos Aires、阿根廷、C1060
- STAT Research S A
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Córdoba、阿根廷、X5014FTO
- Hospital de Ninos de Cordoba
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San Miguel de Tucumán、阿根廷、T4000AXL
- Centro de Investigaciones Medicas Tucuman
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Must have completed the dosing planned in the primary pediatric ustekinumab study
- Benefit of continued ustekinumab therapy (that is, a clinical response or clinical remission as defined in the primary study at the final efficacy visit of the primary study)
- Parent(s) (preferably both if available or as per local requirements), legal guardian(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Informed Consent Process. An adolescent who signs the assent form will be given the opportunity to sign an adult ICF at a later visit when they reach the age of majority during the study to indicate that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
- Females of childbearing potential must have a negative urine pregnancy test at enrollment and prior to study intervention administration
Exclusion Criteria:
- Are pregnant, nursing, or planning pregnancy or fathering a child
- Have had any of (a) confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2 [COVID-19]) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection: Exception: (i) may be included with a documented negative result for a validated SARS-CoV-2 test: obtained at least 2 weeks after conditions (a), (b), (c) above (timed from resolution of key clinical features if present, example, fever, cough, dyspnea) and (ii) with absence of all conditions (a), (b), (c) above during the period between the negative test result and the baseline study visit
- Taken any disallowed therapies as noted in the primary study, before the planned first long-term extension (LTE) dose of study intervention
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participants who receive a live vaccination may be permitted to remain in the study, if approved by the sponsor and study intervention is held for a period of time specified by the sponsor. Receipt of a live severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccine (against the virus that causes Coronavirus Disease 2019 [COVID-19]) is not automatically an exclusion criterion and must be discussed with the medical monitor
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Ustekinumab
Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004, CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Participants enrolling from the Exposure Optimization Substudy may be eligible to remain on the every 4 weeks (q4w) dosing regimen. |
Ustekinumab will be administered as a SC injection.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of Participants With Adverse Events (AEs)
大体时间：Up to 6 years and 4 months
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. |
Up to 6 years and 4 months
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Number of Participants With Serious Adverse Events (SAEs)
大体时间：Up to 6 years and 4 months
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A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Up to 6 years and 4 months
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Number of Participants with AEs Leading to Discontinuation of Study Intervention
大体时间：Up to 6 years and 4 months
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Number of participants with AEs leading to discontinuation of study intervention will be reported. |
Up to 6 years and 4 months
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Number of Participants with AEs of Interest
大体时间：Up to 6 years and 4 months
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Number of participants with AEs of special interest (any newly identified malignancy case of active tuberculosis [TB], or opportunistic infection occurring after the first administration of study intervention[s]) will be reported. |
Up to 6 years and 4 months
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Number of Participants with Abnormalities in Clinical Laboratory Parameters
大体时间：Up to 6 years and 4 months
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Number of participants with abnormalities in clinical laboratory parameters (such as hematology and serum chemistry) will be reported. |
Up to 6 years and 4 months
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Number of Participants with Injection-site Reactions
大体时间：Up to 6 years and 4 months
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Number of participants with injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site. |
Up to 6 years and 4 months
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Number of Participants With AEs of Worsening of the Disease
大体时间：Up to 6 years and 4 months
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Number of participants with AEs of worsening of the disease will be reported. |
Up to 6 years and 4 months
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Number of Participants With Concomitant Therapy due to Loss of Response
大体时间：Up to 6 years and 4 months
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Number of participants with concomitant therapy due to loss of response will be reported. |
Up to 6 years and 4 months
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合作者和调查者
调查人员
- 研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CR109074
- 2020-004457-76 (EudraCT编号)
- CNTO1275ISD3001 (其他标识符：Janssen Research & Development, LLC)
- 2022-501067-40-00 (注册表标识符：EUCT number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.