Impact of a Nurse's Specific Information on the Acceptability of Biosimilars in Chronic Inflammatory Rheumatism
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Observed rate of prescribed biosimilars
研究概览
简要总结
Patients with rheumatoid arthritis or spondyloarthritis, currently treated or about to be started with anti-TNF original drug adalimumab or etanercept will be included and randomized to either " information leaflet only " or " information leaflet + nurse information " arms, just before they see their rheumatologist for periodic assessment of disease and treatment.
Patients from the " information leaflet only " arm will be distributed individually a dedicated leaflet with written generic informations about the use of biosimilars in rheumatic diseases (individual and societal advantages, pharmaceutical development, scientific efficacy and safety results).
Patients from the " " information leaflet + nurse information " arm will be delivered the same leaflet, and additionally offered to have a dedicated individual interview with a specialist nurse, who will orally discuss informations about biosimilars based on a standardized talk, completed by answers to any questions by the patient.
The rheumatologist will then propose, unless inappropriate based on clinical evaluation of the patient, a change in the treatment of patients from the original drug to the corresponding biosimilar.
The primary outcome will be the observed proportions of patients actually receiving the biosimilar drug at the 6-months follow-up visit in the 2 compared arms.
Secondary outcomes will be average time spent by the nurse to adequatley inform the patient, the proportion of patients from the intervention arm who have actually asked for the nurse information interview, and the reasons for refusal of biosimilars, when appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and over (no upper age limit)
- •All adult patients seen in rheumatology consultation at the Montpellier Hospital
- •With inflammatory rheumatism (rheumatoid arthritis or spondyloarthritis).
- •Treated (or in the process of being treated at the end of the consultation) by etanercept or adalimumab
- •In whom the biomedical treatment already used should in principle be renewed without modification (patient deemed good responder and well tolerant of the treatment)
- •Or where biomedical initiation has just been indicated during the consultation
- •Member of a social security scheme
- •Informed and written consent
排除标准
- •Unable to understand information (not fluent in the French language, severe cognitive impairment, etc.)
- •Known intolerance to one of the proposed biosimilar excipients
- •Vulnerable persons: pregnant woman, minor patient, deprived of liberty, under guardianship or under curatorship
研究组 & 干预措施
Nurse information
The patient will receive a generic information leaflet plus an Individual information by nurse on biosimilars
干预措施: Individual information by nurse on biosimilars (Other)
Information Leaflet
The patient will receive a generic information leaflet only
干预措施: Generic information leaflet (Other)
结局指标
主要结局
Observed rate of prescribed biosimilars
时间窗: 18 months
The measure is the number of patient who accept the biosimilars
次要结局
- Proportion of patients from the intervention arm having actually received specific information by nurse(18 months)
- Average time spent by nurse to inform patients(18 months)
- Reasons for refusal of biosimilars(18 months)