A Multi-Center Post Marketing Observational Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed HUMIRA® (Adalimumab) as Part of Routine Clinical Care in Russia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 252
- 试验地点
- 43
- 主要终点
- Characteristics of Patients Prescribed Adalimumab: Disease Severity
研究概览
简要总结
The primary objective of this post-marketing observational study was to obtain data on the characteristics (patient age/gender; disease type, severity and duration; disease specific treatment history; current concomitant medications; other relevant medical history) of patients prescribed adalimumab (Humira®) for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) as part of routine clinical care in Russia.
详细描述
This is a non-interventional, observational study in which adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exist that characterize patient types and adalimumab administration within the Russian population. Further, it is important to characterize the compliance, acceptability of patient self-injection, tolerability and safety profile of this therapy option with the routine clinical care.
The total follow-up for each participant was planned to be 12 months, with approximately 6 follow-up visits occurring at average intervals of 2-3 months. However, since this was an observational study, follow-up was performed according to routine clinical practice; for 127 participants the follow-up period consisted of more than 12 months and the maximum observation period lasted 18.2 months. Follow-up visits were designated sequential visit numbers (Visit 1-6), regardless of the time point at which they occurred.
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
- •Patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:
- •Patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.
- •Patients who completed Abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.
排除标准
- •The following patients will not be included in the study:
- •Patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.
- •Hypersensitivity to adalimumab
- •Pregnancy
- •Lactation
- •Age below 18
- •Infectious diseases including tuberculosis
- •Patients currently participating in another clinical trial.
结局指标
主要结局
Characteristics of Patients Prescribed Adalimumab: Disease Severity
时间窗: Baseline
Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.
Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment
时间窗: Baseline and at each follow-up visit (up to a maximum of 18.2 months).
Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs \[NSAIDs\], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.
Characteristics of Patients Prescribed Adalimumab: Occupation
时间窗: Baseline
Participants were asked to indicate their occupation at the Baseline visit.
Characteristics of Patients Prescribed Adalimumab: Residence Status
时间窗: Baseline
Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.
Characteristics of Patients Prescribed Adalimumab: Education Level
时间窗: Baseline
Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.
Characteristics of Patients Prescribed Adalimumab: Marital Status
时间窗: Baseline
Participants were asked to indicate their marital status at the Baseline visit.
Characteristics of Patients Prescribed Adalimumab: Duration of Disease
时间窗: Baseline
Duration of disease was defined as the time from diagnosis until study entry.
次要结局
- Percentage of Participants With Missed or Delayed Injections(For the duration of the study (up to a maximum of 18.2 months).)
- Duration of Treatment With Adalimumab(For the duration of the study (up to a maximum of 18.2 months).)
- Patient's Acceptability of Self-injections(Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.)