Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 427
- 主要终点
- Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months
研究概览
简要总结
The objective of this post-marketing observational study (PMOS) was to evaluate the effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) in the routine clinical setting in Hungary.
详细描述
This was a prospective, open label, multicenter, observational cohort study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. AbbVie offered an array of services as part of a patient support program, called AbbVie Care 2.0, to study participants. The purpose of the AbbVie Care 2.0 program was to provide educational resources that aimed to help participants understand their health condition and disease management (e.g., lifestyle - exercise or diet), but also help to them understand how to administer the product safely and be empowered to stay on track with their prescribed treatment plan, all with the goal of maximizing patient outcomes. There were five target visits: a baseline visit at enrollment and follow-up visits at 3, 6, 9 and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 未提供
排除标准
- •Participants who could not be treated with adalimumab according to the local adalimumab SmPC and local professional and reimbursement guidelines
- •Participants treated with > 1 prior biologic disease modifying anti rheumatic drug (DMARD) for RA, AS, PsA, Ps, UC or CD
- •Prior treatment with adalimumab for more than 1 month
- •Participants currently participating in other clinical research studies
- •Participants who were unwilling or unable to complete the quality of life and other patient-reported questionnaires
结局指标
主要结局
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months
时间窗: Baseline (Month 0) and 12 months
The health assessment questionnaire Short Form 36 Version 2.0 (SF-36 V2 ) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Positive numbers indicate improvement from baseline.
次要结局
- Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Hospital Inpatient Days and Number of Sick Leave Days(12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months))
- Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at 12 Months(Baseline (Month 0) and 12 months)
- Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score at 12 Months(Baseline (Month 0) and 12 months)
- Mean Change From Baseline in Total Satisfaction With Information About Medicines Scale (SIMS) Score at 12 Months(Baseline (Month 0) and 12 months)
- Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS ESR) at 12 Months(Baseline (Month 0) and 12 months)
- Correlation Between the Length of AbbVie Care 2.0 Duration and Participant Outcomes(From Baseline (Month 0) to 12 months)
- Mean Change From Baseline in Total Morisky Medication Adherence Scale, 4 Questions (MMAS-4) Score at 12 Months(Baseline (Month 0) and 12 months)
- Mean Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Score at 12 Months(Baseline (Month 0) and 12 months)
- Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Outpatient Visits(12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months))
- Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale Score at 12 Months(Baseline (Month 0) and 12 months)
- Mean Change From Baseline in Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) Score at 12 Months in Participants With Crohn's Disease and Ulcerative Colitis(Baseline (Month 0) and 12 months)
- Mean Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at 12 Months in Participants With Ankylosing Spondylitis and Participants With Psoriatic Arthritis With Axial Symptoms(Baseline (Month 0) and 12 months)
- Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (TSQM) Version 1.4 Score at 12 Months(Baseline (Month 0) and 12 months)
- Mean Change From Baseline in Disease Activity Score 28 (DAS28) at 12 Months(Baseline (Month 0) and 12 months)
- Participants' Rating of the AbbVie Care 2.0 Program at 12 Months(12 months)
- Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at 12 Months in Participants With Psoriasis and Psoriatic Arthritis(Baseline (Month 0) and 12 months)
- Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Hospitalizations and Number of Sick Leaves(12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months))
- Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Score at 12 Months(Baseline (Month 0) and 12 months)
- Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 12 Months(Baseline (Month 0) and 12 months)
- Mean Change From Baseline in Partial Mayo (pMayo) Score at 12 Months(Baseline (Month 0) and 12 months)
- Correlation Between Disease Activity Scores and Disease-specific Quality of Life Scores(Baseline (Month 0) and 12 months)