Apremilast 在白塞病或幼年型银屑病关节炎相关口腔溃疡患儿中的研究
Apremilast 在 2 岁或以上患有与白塞病相关的口腔溃疡或 5 岁或以上患有幼年型银屑病关节炎的儿童中进行的一项 3 期、多中心、开放标签、长期扩展研究
The primary objective of this study is to evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Amgen Call Center
- 电话号码：866-572-6436
- 邮箱：medinfo@amgen.com
学习地点
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Kfar Saba、以色列、4428164
- 招聘中
- Meir Medical Center
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Ankara、土耳其（türkiye）、06100
- 招聘中
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Istanbul、土耳其（türkiye）、34098
- 招聘中
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
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Istanbul、土耳其（türkiye）、34764
- 招聘中
- Umraniye Egitim ve Arastirma Hastanesi
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Thessaloniki、希腊、54642
- 招聘中
- General Hospital of Thessaloniki Ippokrateio
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Madrid、西班牙、28034
- 招聘中
- Hospital Universitario Ramon y Cajal
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Valencia
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Valencia、Valencia、西班牙、46026
- 招聘中
- Hospital Universitari i Politecnic La Fe
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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:
- Informed consent / assent obtained
- Must have completed Week 52 on treatment on core study and must be < 18 years of age at the time the informed consent document is signed
- Age and sex specific body mass index (BMI) no lower in range than the 5th percentile on Centers for Disease Control (CDC growth chart) at enrollment
- Willing to adhere to study visit schedule and protocol requirements
- Must have acceptable benefit/risk for continued treatment with apremilast
Exclusion Criteria:
- Answer "yes" to any question on C-SSRS at Week 52 visit of core study
- Scheduled surgery or other interventions that would interrupt study participation
- Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for 30 days after last dose
- Female participants planning to become pregnant while on study through 30 days after last dose
- Female participants of childbearing potential with positive pregnancy test at Week 0
- Known sensitivity to any products to be administered during dosing
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：并行分配
- 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：Apremilast
Participants with a weight between ≥ 12 kg to < 20 kg will receive apremilast 10 mg BID (twice a day), participants with a weight between ≥ 20 kg to < 50 kg will receive 20 mg BID, and participants with a weight ≥ 50 kg will receive apremilast 30 mg BID. |
Oral tablets or liquid suspension
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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体重基线的变化
大体时间：最长约 4 年
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最长约 4 年
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高度从基线变化
大体时间：最长约 4 年
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最长约 4 年
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身体质量指数 (BMI) 相对于基线的变化
大体时间：最长约 4 年
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最长约 4 年
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生命体征有临床显着变化的参与者人数
大体时间：最长约 4 年
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最长约 4 年
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实验室参数发生临床显着变化的参与者人数
大体时间：最长约 4 年
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最长约 4 年
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Number of Participants with Adverse Events
大体时间：Up to approximately 4 years
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Adverse events will be classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. |
Up to approximately 4 years
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Columbia-Suicide Severity rating Scale (C-SSRS)
大体时间：Up to approximately 4 years
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A questionnaire used to assess suicide risk. |
Up to approximately 4 years
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Tanner Staging
大体时间：Up to approximately 4 years
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Tanner Staging of sexual development assessment will be used to assess sexual maturity. |
Up to approximately 4 years
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合作者和调查者
赞助
调查人员
- 研究主任：MD、Amgen
出版物和有用的链接
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
- 20190531
- 2022-003024-41 (EudraCT编号)
- 2023-503433-21 (其他标识符：EU CT number)
- 2023 (美国 NIH 拨款/合同)
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
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD 共享时间框架
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD 共享访问标准
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
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
在美国制造并从美国出口的产品
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.