Hidradenitis Suppurativa Patients' Experience of Treatment With Adalimumab
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of days between each dose for all subjects
研究概览
简要总结
Hidradenitis suppurativa (HS) is a chronic relapsing condition with significant psychosocial impact and morbidity, but that doesn't mean that patients will necessarily be adherent to recommended treatments. Patients, especially those on chronic medication therapy, inevitably miss doses. They use too little or too much therapy. They may take medications too soon or too far apart. While adherence to injection treatments tend to be better than adherence to topical or oral treatment, adherence to injections may still be poor.
Traditional methods for measuring medical adherence-including questionnaires, surveys, and diaries- tend to be unreliable overestimate adherence. Chemical markers are problematic because of the tendency for patients to use their medication right before visits, so called "white coat compliance." Our research team has pioneered the use of electronic monitoring devices which measure and record the date and time of medication events to assess adherence in dermatology. The study team have demonstrated the feasibility of using such monitors to measure adherence to adalimumab in patients with psoriasis. Although only a small study, it documented a broad range of how patients use adalimumab and found that adherence was poor in about half of the patients. While the impact of psoriasis on patients' lives is large, adherence is still poor. How adherent patients with hidradenitis are to weekly adalimumab treatment is not yet well characterized.
详细描述
This is a prospective single-center open-label randomized 6 month study. There will not be a washout period. Treatment will be for 26 weeks.
Subjects will have baseline disease severity assessments. Subjects will be instructed to take adalimumab according to the labelled dosing regimen. Subjects will be randomized to either standard-of-care or to an electronic reporting intervention.
The reporting intervention consists of reporting the experience with the treatment (whether the treatment was taken, the efficacy of the treatment, and any issues that have come up) at weekly intervals for 6 weeks, then every 4 weeks thereafter.
Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit.
Primary Endpoints: Adherence to adalimumab treatment
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Subjects will be randomized to either standard-of-care or to an electronic reporting intervention.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ages 18 - 70
- •Diagnosis of HS for which adalimumab is indicated according to the adalimumab prescribing information.
- •All subjects must have a negative TB skin test according to prescribing guidelines.
- •Subjects must be starting adalimumab for the first time, prescribed by their dermatologist.
排除标准
- •All experimental drugs or devices are to be discontinued at least 1 month prior to initiation of study therapy.
- •Subjects who are receiving biologic therapy with a potential therapeutic impact on hidradenitis within 3 months will be excluded.
- •Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
- •Subjects who have received live vaccines within a 3 month period prior to enrollment will also be excluded.
- •In addition, subjects who have any skin condition or disease that may require concurrent therapy or may confound the evaluation
研究组 & 干预措施
Standard-of-Care
Subjects will be instructed to take adalimumab according to the labeled dosing regimen. Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit.
干预措施: Adalimumab (Drug)
Electronic Reporting
Subjects will be instructed to take adalimumab according to the labeled dosing regimen. The electronic reporting intervention consists of reporting the experience with the treatment (whether the treatment was taken, the efficacy of the treatment, and any issues that have come up) at weekly intervals for 6 weeks, then every 4 weeks thereafter.
Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit.
干预措施: Electronic Reporting (Other)
Electronic Reporting
Subjects will be instructed to take adalimumab according to the labeled dosing regimen. The electronic reporting intervention consists of reporting the experience with the treatment (whether the treatment was taken, the efficacy of the treatment, and any issues that have come up) at weekly intervals for 6 weeks, then every 4 weeks thereafter.
Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Number of days between each dose for all subjects
时间窗: week 26 post randomization
assessment of adalimumab treatment
Percentage of patients who achieve adherence success
时间窗: week 26 post randomization
percentage who have taken over 90% of correct doses of study drug
次要结局
- Physician Global Assessment (PGA)(week 26 post randomization)
- Hidradentis Suppurativa Clinical Response (HiSCR)(week 26 post randomization)
- Dermatology Life Quality Index (DLQI)(week 26 post randomization)
- Number of Doses Missed(week 26 post randomization)
- Number of Doses Taken(week 26 post randomization)
- Total Time in Study(week 26 post randomization)