NCT02739828已完成不适用
Post Marketing Observational Study to Assess Quality of Life Changes in Swedish Patients With Moderate or Severe Hidradenitis Suppurativa (HS) After 6 Months on Adalimumab Treatment (HOPE Study)
AbbVie11 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年4月7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
- 24
- 试验地点
- 11
- 主要终点
- Change From Baseline in DLQI at Week 12
研究概览
简要总结
The objective of this study is to assess quality of life (QoL), skin pain, work productivity/activity and health related problems in Swedish patients with moderate to severe HS before and after 6 months treatment with Adalimumab. Participants will be treated in accordance with normal routine clinical care.
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
- •Diagnosis of Hidradenitis Suppurativa
- •Prescribed Adalimumab according to the Summary of Product Characteristics (SmPC)
- •Willingness to sign and date a Patient Information/Informed Consent Form
排除标准
- •Prior biologic treatment discontinued <6 months before the baseline visit
- •Patient not able to understand the language of the provided patient questionnaires
- •History of non-compliance with medication or a medical history that could enhance non-compliance with medication, as determined by the investigator
结局指标
主要结局
Change From Baseline in DLQI at Week 12
时间窗: Baseline, Week 12
DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
次要结局
- Change From Baseline in DLQI at Week 4(Baseline, Week 4)
- Change From Baseline in DLQI at Week 24(Baseline, Week 24)
- Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 4(Baseline, Week 4)
- Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 12(Baseline, Week 12)
- Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 24(Baseline, Week 24)
- EQ-5D Questionnaire Responses at Week 4(Baseline, Week 4)
- EQ-5D Questionnaire Responses at Week 12(Baseline, Week 12)
- EQ-5D Questionnaire Responses at Week 24(Baseline, Week 24)
- Change From Baseline in EQ-5D VAS Score at Week 24(Baseline, Week 24)
- Change From Baseline in HSIA Overall Score at Week 4(Baseline, Week 4)
- Change From Baseline in HSIA Overall Score at Week 12(Baseline, Week 12)
- Change From Baseline in EQ-5D VAS Score at Week 4(Baseline, Week 4)
- Change From Baseline in EQ-5D VAS Score at Week 12(Baseline, Week 12)
- Change From Baseline in HSIA Overall Score at Week 24(Baseline, Week 24)
- WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 4(Baseline, Week 4)
- WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 12(Baseline, Week 12)
- WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 24(Baseline, Week 24)
- WPAI-SHP: Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 4(Baseline, Week 4)
- Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 12(Baseline, Week 12)
- Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 24(Baseline, Week 24)
- Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 4(Baseline, Week 4)
- Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 12(Baseline, Week 12)
- Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 24(Baseline, Week 24)
- Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4(Baseline, Week 4)
- Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12(Baseline, Week 12)
- Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24(Baseline, Week 24)
- Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4: Participants Not Employed at Baseline(Baseline, Week 4)
- Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12: Participants Not Employed at Baseline(Baseline, Week 12)
- Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24: Participants Not Employed at Baseline(Baseline, Week 24)
- Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time(Week 4, 12 and 24)
研究者
研究点 (11)
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