NCT03223012已完成不适用
Post-marketing Prospective, Observational Cohort Study to Evaluate the Impact of AbbVie Care Patient Support Program on Compliance With Adalimumab, Patient Reported Outcomes and Health Resource Utilization in Inflammatory Bowel Diseases, Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis and Psoriasis in Portugal
AbbVie15 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2017年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 15
- 主要终点
- Proportion of patients with Medication Possession Ratio (MPR)>=80%
研究概览
简要总结
This study aims to evaluate the impact of AbbVie Care 2.0 on adalimumab's compliance, patient reported outcomes and utilization of health resources over 12 months.
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
- •Diagnosed with crohn's disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (SpA) or psoriasis (Pso) according to the treating physician
- •Adalimumab was started within 1 month prior to study enrollment
- •Adalimumab was introduced based on current clinical practice criteria (i.e., the prescription of adalimumab was clearly separated from the decision to include the participants in this study)
- •No prior record of adalimumab treatment
- •Adalimumab was administered according to product label
- •Naïve or previously experienced with biologic treatment
- •Participant is able and willing to provide written authorization to disclose and use personal health information (informed consent), and to agree that data will be collected and provided to AbbVie
- •AbbVie Care 2.0 Cohort-specific inclusion criteria:
- •Initiated the AbbVie care program within the first month after starting adalimumab.
排除标准
- •Definitive discontinuation of adalimumab before being proposed to participate in the study
- •Participated in any clinical experimental research within the 2 months prior to enrollment
- •Pregnant or breastfeeding female participants
- •Participant not able or not willing to comply with the requirements of this study protocol.
结局指标
主要结局
Proportion of patients with Medication Possession Ratio (MPR)>=80%
时间窗: Up to 12 months
The variable MPR will be used, considering in the numerator the sum of days supply between start of observation (baseline) and last prescription dispensed (including the days of last prescription) and as denominator the number of days elapsed between baseline and last prescription dispensed (including the days of last prescription).
次要结局
- Assessing Patient's overall satisfaction with AbbVie Care 2.0 program(At 12 months)
- Mean number of injections administered/ prescribed for adalimumab(Up to 12 months)
- Number of Sick Leaves(Up to 12 months)
- Time Spent by the Patient to Refill Prescription(Up to 12 months)
- Number of Hospital Inpatient Days(Up to 12 months)
- Number of Hospitalizations(Up to 12 months)
- Time Spent by the Health Care Providers (HCPs) During Medical Appointments(Up to 12 months)
- Mean Change in Patient Activation Measure (PAM-13)(From Month 0 to Month 12)
- Number of Emergency Visits(Up to 12 months)
- Assessing Working Status(Up to 12 months)
- Proportion of patients with MPR>=80%(At Month 6)
- Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM)-II(Up to Month 12)
- Mean Change in EuroQoL (EQ-5D) score(From Month 0 to Month 12)
- Number of Complementary Exams/ Techniques(Up to 12 months)
- Mean Change in Beliefs about Medication Questionnaire (BMQ)(From Month 0 to Month 12)
- Change in Work Productivity and Activity Impairment- General Health (WPAI-GH)(From Month 0 to Month 12)
- Number of Outpatient Visits (in-office and remote) in Hospital Setting(Up to 12 months)
- Number of Days of Sick Leaves(Up to 12 months)
- Proportion of patients who are still on adalimumab after 6 and 12 months(Up to 12 months)
研究者
研究点 (15)
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