Optimization of Cyclosporin Therapy in Atopic Dermatitis Through Multiomic Predictive Models of Treatment Response (DermAtOmics)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of patients with primary non-response to treatment with cyclosporine.
研究概览
简要总结
This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis who require systemic treatment.
详细描述
Primary outcome is the percentage of patients with primary non- response to treatment with cyclosporin. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up. A 12-month recruitment period is planned and about of 100 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporin in the Dermatology Service of La Paz University Hospital and associated Specialty Centers are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate-severe atopic dermatitis who are receiving or have received cyclosporin therapy in the Dermatology Service of La Paz University Hospital and associated Specialty Centers are selected in cohort 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with moderate-severe atopic dermatitis who are going to receive treatment with cyclosporine.
- •Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- •For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- •Participant is willing and able to adhere to the procedures specified in this protocol.
- •Subjects diagnosed with moderate-severe atopic dermatitis who are receiving or have received in the past treatment with cyclosporine.
- •Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- •For children, parent/legal guardian must provide written informed consent. If age >11 years old, the minor must give assent.
- •Participant is willing and able to adhere to the procedures specified in this protocol.
排除标准
- •Subjects participating in a clinical trial in the last three months.
- •Any condition or situation precluding or interfering the compliance with the protocol.
- •Women of childbearing potential must have a negative urine pregnancy test at Screening and Day
- •Women of childbearing potential must commit not to become pregnant. They must be willing to use highly effective contraceptive methods or have practiced sexual abstinence during the study. Highly effective contraceptive methods include oral, intravaginal, or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomised partner and sexual abstinence.
研究组 & 干预措施
Start of Cyclosporin treatment
Patients will receive the starting dose used in routine clinical practice (maximum dose of 3 mg/kg/day is standard practice in our center).
Once the patient is included in the clinical trial their therapeutic management will be carried out according to usual clinical practice, but additional procedures will be performed:
- The frequency of follow-up visits will be increased in order to collect data related to clinical efficacy, safety and quality of life;
- Biological samples will be obtained (blood and urine) for biochemical, kinetic, pharmacogenetic and immunological biomarker analysis to identify variables associated to CsA treatment.
干预措施: Cyclosporin A (Drug)
Receiving or received cyclosporin
If the patient is receiving cyclosporine therapy, a blood sample for pharmacogenetic analysis will be obtained at screening; also, at discretion of the treating physician, biological samples will be obtained (blood and urine) in this visit and in the follow-up visits to assess biochemical and kinetic variables. Clinical data (scales) will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion.
If the patient received cyclosporine previously but is no longer under CsA therapy, a blood sample will be extracted at screening for pharmacogenetic analysis. Clinical data (scales) will be collected from clinical records.
干预措施: Follow-up of Cyclospoin treatment already started (Other)
结局指标
主要结局
Percentage of patients with primary non-response to treatment with cyclosporine.
时间窗: Week 16
Fail to achieve EASI-75 (a 75% improvement in EASI score)
次要结局
- Time to treatment failure after week 16(Week 24, week 32, week 40, week 48.)
- Percentage of change in SCORAD(Week 16)
- Percentage of patients having a variation of 4 points in their improvement in DLQI(through study completion, an average of 1 year)
- Mean percentage of change in EASI score(Week 16)
- Change of BSA(week 16)
- Percentage of patients reaching EASI-90(through study completion, an average of 1 year)
- improvement of at least 75% in SCORAD(through study completion, an average of 1 year)
- Change of IGA(week 16)
- Percentage of patients achieving EASI-75(week 6)
- Time to IGA score of 0/1(through study completion, an average of 1 year)
- Change in NRS(week 16)
- Change in POEM(week 16)
- Change in DLQI(week 16)
- Rate of adverse events associated to CsA treatment(through study completion, an average of 1 year)