Prospective, Multi-Center, Observational, Program to Assess Retention Rate, Persistence and Adherence in Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated With Adalimumab in Routine Clinical Settings in Russian Federation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 14
- 主要终点
- Proportion of participants on adalimumab therapy
研究概览
简要总结
The objective of this study is to access retention rate, persistence and adherence in population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis (PsA)) participants treated with adalimumab in routine clinical settings in the Russian Federation.
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
- •Confirmed diagnosis of AS or PsA.
- •Planned prescription or prescribed no more than 1 month before to enrolment therapy with adalimumab. Treatment has to be prescribed according to the local product label and prescription guidelines.
- •At the moment of start of treatment with adalimumab moderate/severe AS or PsA (BASDAI > 4 for AS; DAS28 >3,2 for PsA).
- •Negative result of tuberculosis (TB) screening test and TB specialist permission to start biologic therapy.
- •Authorization (Consent) for Use/Disclosure of Data signed by the participant.
排除标准
- •Has contraindications for the treatment with adalimumab (please see the latest version of the locally approved label).
- •Participants who are unable to walk and perform basic self-care activities either due to SpA or a comorbid condition.
- •Any biologic drugs taken over before 3 months of enrolment to the study.
- •Previous participation in this program.
结局指标
主要结局
Proportion of participants on adalimumab therapy
时间窗: Up to 30 days after administering last dose in the study (52 weeks)
This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in RA and SpA.
Number of participants on adalimumab therapy
时间窗: Up to 30 days after administering last dose in the study (52 weeks)
This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in rheumatoid arthritis (RA) and SpA.
次要结局
- Assessing medication persistence(Up to 48 weeks of treatment period)
- Change of disease activity in participants with PsA(Up to 48 weeks of treatment period)
- Assessing medication adherence(Up to 48 weeks of treatment period)
- Change of disease activity in participants with AS(Up to 48 weeks of treatment period)