Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Brodalumab and the Development of Concentration-response Curve of Brodalumab of Psoriasis Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Predictive value of early serum trough concentrations of brodalumab
研究概览
简要总结
Biologics, such as brodalumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study we aim to investigate the predictive value of early serum trough levels of brodalumab and determine the therapeutic window of brodalumab in psoriasis patients.
详细描述
Patients will be included after siging informed consent. After inclusion, patients will continue on standard dosing schedule of brodalumab (i.e. one loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks). During each study visit, blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards brodalumab. In addition, the Psoriasis Severity and Area Index (PASI) and the Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
- •Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
排除标准
- •Participants who have currently a predominant nonplaque form of psoriasis
- •Participants who are pregnant, nursing or planning a pregnancy
- •Participants who are unable or unwilling to undergo multiple venapunctures
- •Participants who are treated according to a different dosing schedule than standard dosing of brodalumab
研究组 & 干预措施
Standard of care - brodalumab
Patients will continue to receive brodalumab according to standard care dosing regimen, i.e. loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks.
干预措施: Venapuncture (Procedure)
Standard of care - brodalumab
Patients will continue to receive brodalumab according to standard care dosing regimen, i.e. loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks.
干预措施: Patient questionnaires (Other)
结局指标
主要结局
Predictive value of early serum trough concentrations of brodalumab
时间窗: Week 0 until week 24 of treatment
Prediction of the clinical response (PASI) at week 12 and/or week 25 based on serum trough concentrations measurements taken from week 0, 1, 2, 3 and/or 4.
Predictive value of early anti-drug antibodies of brodalumab
时间窗: Week 0 until week 24 of treatment
Prediction of the clinical response (PASI) at week 12 and/or week 24 based on anti-drug antibodies measurements taken from week 0, 1, 2, 3 and/or 4.
The development of a therapeutic window of brodalumab in psoriasis
时间窗: Week 0 until week 52 of treatment
Defining a therapeutic window for brodalumab based on serum trough levels corresponding with adequate clinical response.
次要结局
- EQ VAS(Week 0 until week 52 of treatment)
- DLQI(Week 0 until week 52 of treatment)
- EQ5D5L(Week 0 until week 52 of treatment)