Improving Clinical Trial Recruitment and Outcome Measures in Bullous Pemphigoid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in Bullous pemphigoid disease area index (BPDAI)
研究概览
简要总结
The purpose of the study is to improve the quality of future clinical trials in bullous pemphigoid (BP), the investigators will monitor repeated measurement data from patients with BP on standard-of-care treatments at four week intervals for four months.
详细描述
The study team plans to recruit 45 subjects from the autoimmune blistering disease clinic at Emory Dermatology Clinic. The plan is to improve the quality of future clinical trials in bullous pemphigoid (BP), the team will monitor repeated measurement data from patients with BP on standard-of-care treatments at four week intervals for four months. This time frame will allow completion of both aims in the three year time period. Aim 1 will evaluate the BPDAI scoring over time with specific reductions in the activity score as future outcomes for therapeutic response and assess changes in patient reported outcomes particularly related to pruritus for future clinical trial endpoints. Aim 2 will focus on the development of teledermatology platform for improving patient recruitment and retention. The data from this proposal will be critical for future BP clinical trials and clarify gaps in the current knowledge related to the natural disease history of BP patients on standard-of-care therapies, changes in BPDAI scores over time, and pruritus specific outcome measures to define the quality of life impact.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Males or females > age 18
- •Clinical and histological confirmation of bullous pemphigoid including at least subepidermal separation on H&E or a positive direct immunofluorescence along with indirect immunofluorescence which demonstrates staining to the roof on salt split skin or ELISA positivity for BP180 and/or BP230 autoantibodies
- •Baseline BPDAI-TAS >5
排除标准
- •Subjects who are unable to consent, language barriers, or other unspecified reason that in the opinion of the investigator makes the subject unsuitable for enrollment. Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with IRB Policies and Procedures.
结局指标
主要结局
Change in Bullous pemphigoid disease area index (BPDAI)
时间窗: Baseline, monthly post-baseline for 4 months, 6 months post-baseline
Change in Bullous pemphigoid disease area index (BPDAI) activity score is the arithmetic sum of 3 subcomponents: cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. Scores can range from 0 to 360 for BPDAI total activity (maximum 240 for total skin activity and 120 for mucosal activity), with higher scores indicating greater disease activity (worse outcome).
次要结局
- Change in Treatment of Autoimmune Bullous Disease Quality of Life (TABQoL) score(Baseline, monthly post-baseline for 4 months, 6 months post-baseline)
- Number of participants with confidence that the teledermatology visit is more convenient than going to the dermatology clinic(Baseline, monthly post-baseline for 4 months, 6 months post-baseline)
- Change in ItchyQol score(Baseline, monthly post-baseline for 4 months, 6 months post-baseline)
- Change in Autoimmune Bullous Disease Quality of Life score (ABQoL)(Baseline, monthly post-baseline for 4 months, 6 months post-baseline)
- Number of participants with confidence that the dermatologist can help by looking at photos(Baseline, monthly post-baseline for 4 months, 6 months post-baseline)
- Number of participants that believe they will use the teledermatology service again(Baseline, monthly post-baseline for 4 months, 6 months post-baseline)
- Change in patient and physician global assessment(Baseline, monthly post-baseline for 4 months, 6 months post-baseline)
- Change in teledermatology satisfaction score(Baseline, monthly post-baseline for 4 months, 6 months post-baseline)
研究者
Ron Feldman
Assistant Professor
Emory University