TREATgermany: German National Clinical Registry: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,800
- 试验地点
- 3
- 主要终点
- Score of Atopic Dermatitis (oSCORAD)
研究概览
简要总结
About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence.
Some children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment with systemic immunomodulating agents or UV-therapy.
Systematic reviews indicate that although several different interventions for moderate-to-severe AD have been studied in clinical trials, strong recommendations are only possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA).
Pharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany).
Large head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative.
In this situation, clinical registries can provide valuable information for evidence-based clinical decision making.
Extension of TREATgermany to children and adolescents is necessary as
- moderate-to-severe AD is frequent in this age group, but the effectiveness of existing topical and systemic agents in the routine care setting on clinical severity, patient-reported outcomes, and the course of AD and associated atopic and non-atopic comorbidities over time is still poorly understood
- it is unclear how many children and adolescents cannot be effectively controlled with the avoidance of trigger factors, patient education, and topical anti-inflammatory treatment alone
- innovative agents will become available for these age groups within the next years and reference data will be necessary to evaluate their effectiveness and indication criteria
- adequate evidence regarding patient needs in children and adolescents with moderate-to-severe AD is urgently needed to provide value-based healthcare for this vulnerable patient group
- Best-practice models of transition from adolescent to adult care of patients with moderate-to-severe AD do not exist yet, but constitute a prerequisite for the establishment of efficient patient care
详细描述
Study procedures:
No study related intervention will be performed. Included patients will be prospectively followed for at least 24 months. A maximum duration of follow-up is not intended.
During the observation period standardized study visits are performed to prospectively document patient characteristics, clinical data, patient-reported outcomes, physician's reasons for treatment decisions, and satisfaction with treatment.
The first study visit is scheduled at patient inclusion (baseline-visit; V1). The second and third study visits are scheduled 3 and 6 months after baseline, respectively. (V2 after 3 months, V3 after 6 months). Thereafter, study visits are scheduled after 3 months (if a new systemic treatment was initiated) or after 6 months (in case no new systemic treatment was prescribed).
In a subset of patients biosamples for molecular analyses including blood, swabs and stool will be taken at baseline and at V6, as well as skin biopsies prior to and 3 months after systemic therapy initiation. This optional module requires separate patient information and informed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AD according to the United Kingdom (UK) working party diagnostic criteria
- •Moderate to severe AD
- •Objective SCORAD > 20 or Currently anti-inflammatory systemic treatment for AD or Previous anti-inflammatory systemic treatment for AD within past 24 months
排除标准
- 未提供
结局指标
主要结局
Score of Atopic Dermatitis (oSCORAD)
时间窗: Change from Baseline oSCORAD at 2 years
Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis: Dermatology 1993;186:23-31
次要结局
- Patient Oriented Eczema Measure (POEM)(Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years)
- Severity of Pruritus and Sleeping Problems (VAS)(Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years)
- Flares (totally/well controlled weeks)(Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years)
- Eczema Area and Severity Index (EASI)(Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years)
- Health-related Quality of Life (DLQI)(Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years)