NCT04459507已完成不适用
Registry of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 70
- 主要终点
- Percentage of Participants who Remain on Their 'Index Systemic' Therapy
研究概览
简要总结
The purpose of this study is to describe the treatment patterns of participants receiving systemic treatment for of palmoplantar pustulosis (PPP) in Japan.
详细描述
This is a retrospective study where the historical data on PPP therapy will also be used prior to Visit 1 (baseline).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Must have a confirmed diagnosis of palmoplantar pustulosis (PPP) and/or pustulotic arthro-osteitis (PAO) in accordance with local clinical practice
- •Has previously been prescribed treatment for PPP/PAO
- •A decision has been made by the treating physician and the participant to commence treatment with a systemic PPP/PAO therapy, having been deemed to have an inadequate response to previous therapy (New users are defined as those participants to commence treatment on baseline visit date. Existing users are defined as those who commenced treatment prior to the baseline visit since 01 November 2019.)
- •Must sign a participation agreement/informed consent form allowing data collection and source data verification in accordance with local requirements
排除标准
- •Are receiving, or have received within the past 3 months, anti-inflammatory or analgesic systemic therapy such as oral corticosteroid, disease modifying antirheumatic drug (DMARDs), non-steroidal anti-inflammatory drugs, opioids, phosphodiesterase 4 (PDE4) inhibitor, or biologics for any other indication (for example, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and asthma)
- •Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point
- •Participation in an investigational study
- •Participation in another observational study for guselkumab (including a post marketing surveillance study)
- •If the only treatment they have received for PPP has been antibiotics
研究组 & 干预措施
Participants With Palmoplantar pustulosis (PPP)
Participants treated with a new systemic therapy for their PPP, having had an inadequate response to a prior PPP therapy either as their first systemic therapy or as a switch from, or addition to, a previous systemic therapy will be observed. Participants will be treated in accordance with routine clinical practice in Japan in the outpatient specialist care setting. The primary data source for this study will be the medical records of each participant.
干预措施: No intervention (Other)
结局指标
主要结局
Percentage of Participants who Remain on Their 'Index Systemic' Therapy
时间窗: Up to 4.5 Years
Percentage of participants who remain on their 'index systemic' therapy will be reported.
Percentage of Participants Ceasing Their 'Index Systemic' Therapy
时间窗: Up to 4.5 Years
Percentage of participants ceasing their 'index systemic' therapy will be reported.
Time to Cessation of Index Systemic Therapy From Baseline
时间窗: Baseline, Up to 4.5 Years
Time to cessation of index systemic therapy from baseline will be reported.
次要结局
- Percentage of Participants Receiving Each 'Index Systemic' Therapy(Baseline)
- Mean and Distribution of Dermatology Life Quality Index (DLQI) Scores at Baseline(Baseline)
- Mean and Distribution of European Quality of Life (EuroQol) Group, 5-Dimension, 5-Level (EQ-5D-5L) Scores at Baseline(Baseline)
- Mean and Distribution of Work Productivity and Activity Impairment: General Health (WPAI:GH) Scores at Baseline(Baseline)
- Percentage of Participants Adding a Concurrent Systemic Treatment to their 'Index Systemic' Therapy(Baseline and Every 6 Months Up to 4.5 Years)
- Percentage of Participants Ceasing a Concurrent Systemic Treatment to their 'Index Systemic' Therapy(Baseline and Every 6 Months Up to 4.5 Years)
- Time to Addition of a Concurrent Systemic Treatment to 'Index Systemic' Therapy(Baseline and Every 6 Months Up to 4.5 Years)
- Time to Ceasing of a Concurrent Systemic Treatment to 'Index Systemic' Therapy(Baseline and Every 6 Months Up to 4.5 Years)
- Percentage of Participants Changing the Dosage of their 'Index Systemic' Therapy(Baseline and Every 6 Months Up to 4.5 Years)
- Percentage of Participants Adding a Concurrent Non-Systemic Therapy to their 'Index Systemic' Therapy(Baseline and Every 6 Months Up to 4.5 Years)
- Percentage of Participants Ceasing a Concurrent Non-Systemic Therapy to their 'Index Systemic' Therapy(Baseline and Every 6 Months Up to 4.5 Years)
- Percentage of Participants Switching to a First Subsequent Systemic Therapy Within the Follow-up Period(Every 6 Months Up to 4.5 Years)
- Time to Commencement of First Subsequent Systemic Therapy From Baseline(Baseline and Every 6 Months Up to 4.5 Years)
- Percentage of Participants Switching to a Second Subsequent Systemic Therapy Within the Follow-up Period(Every 6 Months Up to 4.5 Years)
- Time to Commencement of Second Subsequent Systemic Therapy From Baseline(Baseline and Every 6 Months Up to 4.5 Years)
- Mean and Distribution of Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline(Baseline)
- Percentage of Participants with a Physician's Global Assessment (PGA) Score of 1 or Less (0 or 1)(Baseline and Every 6 Months Up to 4.5 Years)
- Change From Baseline in PGA Score(Baseline and Every 6 Months Up to 4.5 Years)
- Change from Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Score(Baseline and Every 6 Months Up to 4.5 Years)
- Change From Baseline in Pain Visual Analogue Scale (Pain-VAS) Score(Baseline and Every 6 Months Up to 4.5 Years)
- Change in Primary Location of Pain(Baseline and Every 6 Months Up to 4.5 Years)
- Change From Baseline in DLQI Score(Baseline and Every 6 Months Up to 4.5 Years)
- Change From Baseline in EQ5D-5L Index Score(Baseline and Every 6 Months Up to 4.5 Years)
- Change from Baseline in HAQ-DI Index Score(Baseline and Every 6 Months Up to .4.5 Years)
- Change from Baseline in Work Productivity and Activity Impairment questionnaire (WPAI)(Baseline and Every 6 Months Up to 4.5 Years)
- Percentage of Participants with Adverse Events (AEs) and serious Adverse Events (SAEs)(Up to 4.5 Years)
研究者
研究点 (70)
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