A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15,000
- 试验地点
- 119
- 主要终点
- Evaluate Adverse Events of IMISC and treatment in Clinical Practice
研究概览
简要总结
TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.
详细描述
TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.
The duration of follow-up for participants enrolled in the EU is limited to 5-years. Those within in US and Canada may consent to indefinite follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adults and children (all ages) with Atopic Dermatitis or other Immune-mediated Inflammatory Skin Conditions been prescribed any dermatologic treatment.
- •2. Participant has plans for future visits at the site for continued management of IMISC.
排除标准
- •1. Inability to provide written informed consent/assent.
- •2. Subjects participating in any interventional study or trial for IMISC treatment trial at the time of enrollment. Patients may be enrolled in TARGET-DERM once participation in the trial is complete. Note: Participants may be enrolled in other registries or studies where IMISC treatment outcomes are observed and/or reported (such as center-based registries).
结局指标
主要结局
Evaluate Adverse Events of IMISC and treatment in Clinical Practice
时间窗: 25 Years
Enable characterization of IMISC disease activity and comorbid medical conditions over time.
Characterize IMISC Treatment Regimens in Clinical Practice
时间窗: 25 Years
Enable characterization of IMISC disease activity and comorbid medical conditions over time.
Evaluate Patient Outcomes in Clinical Practice
时间窗: 25 Years
Enable characterization of IMISC disease activity and comorbid medical conditions over time.
次要结局
- Evaluate Patient Reported Outcome (PRO) measures(25 Years)
- Evaluate outcomes related to Patient Support Programs (PSPs)(25 Years)
- Evaluate the relationship between IMISC and comorbid medical conditions(25 Years)