Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 452
- 主要终点
- Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12
研究概览
简要总结
The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.
详细描述
This post-marketing observational study (PMOS) was performed in a multi-country, multi-center, single-arm format. Data were collected prospectively and retrospectively. Adult patients with diagnosis of AS who were assigned for treatment with adalimumab (Humira®) were eligible for participation. Each patient included in this study was to be observed during his/her adalimumab treatment for a maximum of 12 month period. During this period four follow-up visits were planned for observation of the patient and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).
研究设计
- 研究类型
- Observational
- 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
- •Had ankylosing spondylitis (AS) and was eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines,
- •Had been started on adalimumab therapy no more than one (1) month prior to the study enrollment
- •Had negative result of tuberculosis (TB) screening test or was receiving tuberculosis prophylaxis as per local guidelines
- •Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations
排除标准
- •Had contraindications for the treatment with adalimumab
结局指标
主要结局
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12
时间窗: Month 0 (baseline) and Month 12
The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.
次要结局
- Mean Change From Baseline in BASDAI Score(Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF))
- Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score(Month 3, Month 6, Month 9 and Month 12)
- Mean Change in the Number of Sick Leave Days(12 months prior to month 0 (baseline) and 12 months prior to month 12)
- Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider(12 months prior to month 0 (baseline) and 12 months prior to month 12)
- Mean Change in the Number of Hospital Inpatient Days(12 months prior to month 0 (baseline) and 12 months prior to month 12)
- Mean Change in the Number of Sick Leaves(12 months prior to month 0 (baseline) and 12 months prior to month 12)
- Percentage of Participants Achieving BASDAI 50(Month 3, Month 6 and Month 9)
- Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline(Month 3, Month 6, Month 9 and Month 12)
- Mean Change in the Number of Hospitalizations(12 months prior to month 0 (baseline) and 12 months prior to month 12)
- Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score(Month 3, Month 6, Month 9 and Month 12)