Evaluation of Humira Retention Rate in Psoriasis Patients in Daily Practice and Assessment of Work Productivity and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 191
- 主要终点
- Adalimumab Treatment Retention Status
研究概览
简要总结
This observational study will document to what extent in daily clinical practice Humira (adalimumab) therapy is continued, interrupted or permanently discontinued during a follow-up period of 2 years. Reasons for interrupting or permanently discontinuing Humira therapy and reasons for restarting Humira therapy will be noted. An evaluation will be performed of the effect of the disease on quality of life and work productivity.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > or = 18 years
- •Patient with chronic plaque psoriasis
- •Patient newly initiated on Humira
- •Patient compliant with Humira Summary of Product Characteristics
- •Patient compliant with Belgian reimbursement criteria of Humira in plaque psoriasis
- •Patient has signed informed consent
排除标准
- •Patients having any of the contraindications mentioned in the Summary of Product Characteristics Humira
- •Patients not willing to sign informed consent
结局指标
主要结局
Adalimumab Treatment Retention Status
时间窗: Month 24/ Early Termination visit
Percentage of participants with an adalimumab treatment status of continuous, early intermittent, late intermittent, permanently discontinued, or other. Continuous=initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study. Early intermittent=initiated on adalimumab 40 mg, treated every other week (EOW) for \< 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study. Late intermittent=initiated on adalimumab 40 mg, treated EOW for ≥ 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study. Permanently discontinued=received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently. Other=participants not belonging to any of the previous groups.
次要结局
- Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status(Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months))
- Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status(Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months))
- DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status(Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months))
- WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status(Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months))
- WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status(Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months))
- Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status(Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months))
- PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status(Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months))
- Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status(Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months))
- Physician's Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status(Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (obs.; up to 24 months))
- WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status(Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months))