Deucravacitinib Adherence Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Identify Adherence to treatment
研究概览
简要总结
Psoriasis patients are very poorly adherent to topical treatment. If adherence issues are ignored, poor adherence may limit the real-world efficacy of deucravacitinib, too. Forty psoriasis patients recruited from Wake Forest Baptist Health Dermatology Clinic will be enrolled. Twenty will be randomized to a reporting intervention designed to promote better adherence and the remaining 20 patients will serve as controls who will not receive a reporting intervention. Through qualitative interviews of the 40 patients recruited, we plan to study the behaviors of the most adherent patients to better understand specific beliefs and behaviors of adherent patients and to identify practical, modifiable factors that can improve adherence. We will also compare treatment outcomes and efficacy of deucravacitinib between the most and least adherence patients.
详细描述
STUDY OBJECTIVES
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PRIMARY OBJECTIVE: The primary objective of the proposed study is to identify adherence outliers (high and low adherence), specific beliefs, and behaviors that correspond to better and worse adherence to oral treatment of psoriasis.
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SECONDARY OBJECTIVE: The investigators will study the efficacy and safety of deucravacitinib in patients who are highly adherent to treatment compared to patients who do not take the medication as directed (including both those who undertreat and overtreat).
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Safety endpoints will include reported adverse events.
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For the characterization of adherence to deucravacitinib, adherence endpoints will include the proportion of subjects with 80% or greater adherence, days with missed treatment, days with overuse, and premature discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will not be told that the monitors attached to their medication is recording their usage
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate-to-severe plaque psoriasis. Standard criteria for moderate-to-severe plaque psoriasis will be used (BSA greater than or equal to 3% or face/palm/sole/genital involvement or severe effect on Quality of Life).
- •Subject must be 18 years of age or older.
- •Subject must have a working knowledge of English.
- •Approved birth control methods required for females of childbearing potential.
- •Baseline TB test.
排除标准
- •Patients without a diagnosis of moderate-to-severe plaque psoriasis.
- •Patients under 18 years of age.
- •Patients with severe or unstable comorbid conditions.
- •Patients with active malignancy or malignancy in past 5 years (not including appropriately treated cutaneous basal and cutaneous-limited squamous cell carcinomas).
- •Patients who are pregnant or breastfeeding.
- •Patients with any other skin condition that prohibit or confound the ability of the investigator to interpret skin findings.
- •Patients with active substance or alcohol abuse disorder; or history of substance/alcohol abuse disorder within 6 months prior to study enrollment.
- •History of, or active, severe depression and/or suicidality.
- •Patients with active or latent tuberculosis as determined by quant-TB baseline testing
- •Patients that are taking concomitant biologics, systemics for the treatment of psoriasis and/or phototherapy.
结局指标
主要结局
Identify Adherence to treatment
时间窗: 3 month close-out visit
Qualitative data will be obtained from detailed, systematic interviews at 3-month follow-up to Adherence to treatment will be captured using electronic monitors that record the timing of medication dosing events and the number of pills taken at each event (based on weight of medication using Sensal Health adherence monitoring device) measured at 3 month close-out visit
次要结局
- Psoriasis Treatment Efficacy (PASI 75)(baseline and 3 month close-out visit)
- Psoriasis Treatment Efficacy (PASI 90)(baseline and 3 month close-out visit)
- Psoriasis Treatment Efficacy (PASI 100)(baseline and 3 month close-out visit)
- Disease Clarity - Investigator's Global Assessment (IGA) Scale(baseline and 3 month close-out visit)