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Effectiveness of Upadacitinib and Biologics for the Achievement of Minimal Disease Activity in Adults With Moderate-to-Severe Atopic Dermatitis (RAMpUp) (RAMpUp)

2026年7月31日 更新者:AbbVie

A Prospective, Observational Study to Evaluate the Effectiveness of Upadacitinib and Biologics on the Achievement of Minimal Disease Activity in Patients With Moderate-to-severe Atopic Dermatitis (RAMpUp)

Atopic dermatitis (AD) is a common, chronic, inflammatory skin disease with a significant impact on patients' health-related quality of life. In addition to skin lesions, patients often experience pruritis, often at night, which can result in scratching and frequent sleep disturbances. These impacts can subsequently contribute to mental health problems and diminished quality of life. This study aims to evaluate the real-world effectiveness of upadacitinib for the achievement of minimal disease activity and optimal treatment targets in relation to biological treatments in adults with moderate-to-severe atopic dermatitis.

This is a prospective, observational, cohort study to evaluate the effectiveness of upadacitinib and biologics in participants with moderate-to-severe atopic dermatitis. Upadacitinib is an approved selective and reversible JAK inhibitor for the treatment of atopic dermatitis. This study is non-interventional and observational in design. Participants will be prescribed either upadacitinib or an approved biologic treatment for AD as per local country label and prescribing guidelines by their physician independent of study participation. Adult participants with moderate-to-severe AD who are biologic-naive or biologic-experienced will be enrolled. Around 900 participants will be enrolled in the study at multiple sites worldwide.

The study will follow participants for 48 weeks with recommended assessments. The treatment regimen, including route, form, and frequency, will be determined by the physician's usual clinical practice and local prescribing guidelines.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

研究概览

地位

尚未招聘

研究类型

观察性的

注册 (估计的)

900

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

Participants with moderate-to-severe AD prescribed upadacitinib or biological treatments per local country label and physician decision.

描述

Inclusion Criteria:

  • Physician confirmed diagnosis of moderate-to-severe AD validated Investigator's Global Assessment (vIGA-AD ≥ 3) with onset of symptoms ≥ 1 year prior to baseline
  • Biologic-naive or biologic-experienced (use of a biologic treatment for AD within 2 years prior to the baseline visit)
  • Participants initiating upadacitinib or an approved biologic treatment for AD per local label and local prescription guidelines
  • Participants who are willing and able to complete the patient reported questionnaires
  • Participants must voluntarily sign and date an informed consent form approved by an IEC/IRB prior to inclusion in this study (as per local regulations).

Exclusion Criteria:

  • Participation in any interventional trial or observational study (not restricted to AD). Participation in a registry is permitted.
  • Prior use of the AD treatment being evaluated in the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Upadacitinib
Participants initiating upadacitinib for the management of moderate-to-severe atopic dermatitis per local country label and physician decision. Treatment prescribed in accordance with the terms of local country authorization and professional and reimbursement guidelines.
Biologics
Participants initiating approved biologic treatments for moderate-to-severe atopic dermatitis per local country label and physician decision. Treatment prescribed in accordance with the terms of local country authorization and professional and reimbursement guidelines.

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
Percentage of Participants Achieving Minimal Disease Activity (MDA)
大体时间:At Week 16

Achievement of MDA defined as Eczema Area and Severity Index (EASI ≤ 3) and Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1.

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD: Clear=0, Almost clear=0.1-1.0, Mild=1.1-7.0, Moderate=7.1-21.0, Severe=21.1-50.0, Very severe=50.1-72.0 Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable)

At Week 16

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 研究主任:ABBVIE INC.、AbbVie

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月30日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2029年3月1日

研究注册日期

首次提交

2026年7月16日

首先提交符合 QC 标准的

2026年7月31日

首次发布 (实际的)

2026年8月3日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月31日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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