A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 7
- 主要终点
- Clinical response
研究概览
简要总结
The optimal therapeutic serum trough level (Ctrough) of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab Ctrough above this therapeutic range did not add clinical response. Based on this therapeutic window, the introduction of dose adjustments based on Ctroughs (therapeutic drug monitoring) will be further validated in a prospective randomized-controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab Ctroughs, dose reduction is able to maintain favorable clinical outcome.
详细描述
Patients will be included after signing informed consent and randomized in either a standard dose arm or a concentration based arm based on prior Ctrough measurements. In the concentration based arm, dosing frequency will be lowered to once every 3 weeks. If patients still have supratherapeutic Ctroughs of adalimumab, these patients will continue adalimumab self-administration every 4 weeks. In the standard based arm, patients will continue on standard dosing schedule. During each study visit blood will be taken in order to quantify Ctroughs. In addition, Psoriasis Area and Severity Index (PASI) and 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. In addition, in a subset of patients in each treatment arm, additional sampling will be collected by dried blood spot sampling in order to build a PK(PD) model for adalimumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 for at least 6 months prior to inclusion
- •Participants must have a stable disease during maintenance on adalimumab (absolute PASI < 3)
- •Participants are not allowed to use topical steroids from 7 days before randomization until the end of the study (week 48).
- •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 while enrolled in the study or within 12 weeks after receiving the last administration of study intervention
- •Participants who are unable or unwilling to undergo multiple venapunctures
- •Participants who are treated according to a different dosing schedule than standard dosing of adalimumab (regular dose regimen every 2 weeks; 40 mg)
研究组 & 干预措施
Standard dosing group
Patients will continue to receive adalimumab according to the standard dosing schedule.
干预措施: Venapuncture (Procedure)
Standard dosing group
Patients will continue to receive adalimumab according to the standard dosing schedule.
干预措施: Dried blood spot (Procedure)
Dose tapering group
Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab.
干预措施: Venapuncture (Procedure)
Dose tapering group
Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab.
干预措施: Dried blood spot (Procedure)
Dose tapering group
Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab.
干预措施: Dose reduction (Drug)
结局指标
主要结局
Clinical response
时间窗: Week 0- Week 48
The proportion of patients in each group in clinical remission (absolute PASI \< 2) at year 1 after optimization
次要结局
- The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab.(Week 0- Week 48)
- Relapse(Week 0- Week 48)
- The proportion of patients in each group with serum trough levels of adalimumab within the optimal interval.(Week 0- Week 48)