Switch From Intravenous to Subcutaneous Infliximab (REMSIMA®) in Clinical Practice in the Rheumatology Department of Cochin Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percentage of patients who have agreed to receive SubCutaneous (SC) REMSIMA® and who continued this treatment for at least 6 months.
研究概览
简要总结
TNFα inhibitors have revolutionized the management of patients suffering from inflammatory diseases in the field of rheumatology. Infliximab remains widely used in France, and infliximab biosimilars have been routinely used since 2015 in Cochin Hospital with an interchangeability strategy validated by two real life studies. REMSIMA® 120 mg is the first authorized subcutaneous (SC) form of infliximab to be administered at a fixed dose of 120 mg every 2 weeks. Scarce information is available regarding the safety and efficacy of proposing a switch from IV infliximab to SC REMSIMA® in the subsets of patients suffering from different rheumatic diseases in daily care. The primary objective of the SIC2 study will be determine the retention rate of Remsima SC at 6 months. The investigators will recruit adult patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis.
详细描述
TNFα inhibitors have revolutionized the management of patients suffering from inflammatory diseases in the field of rheumatology. Infliximab remains widely used in France, and infliximab biosimilars have been routinely used since 2015 in Cochin Hospital with an interchangeability strategy validated by two real life studies. REMSIMA® 120 mg is the first authorized subcutaneous (SC) form of infliximab to be administered at a fixed dose of 120 mg every 2 weeks. Scarce information is available regarding the safety and efficacy of proposing a switch from IV infliximab to SC REMSIMA® in the subsets of patients suffering from different rheumatic diseases in daily care. The primary objective of the SIC2 study will be determine the retention rate of Remsima SC at 6 months. The investigators will recruit adult patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis. Main inclusion criteria will be patients who have received at least 3 IV infliximab infusions and suffer from chronic inflammatory rheumatic condition with the absence of disease flare / progressive disease preventing the continuation of infliximab. The primary endpoint will be the percentage of patients who have agreed to receive SC REMSIMA® and who continued this treatment for at least 3 months. Secondary objectives will be the reasons of switching or not to Remsima, the need for patients to be re-established on iv infliximab, SC Remsima® discontinuation and adherence, changes in disease activity between the inclusion visit and the last visit, the safety profile of sc remsima®, the immunogenicity profile of sc remsima®.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 or older
- •Patients who has received at least 3 IV infliximab infusions and suffer from chronic inflammatory rheumatic condition
- •Absence of disease flare / progressive disease preventing the continuation of infliximab
- •Patient affiliated to national insurance
排除标准
- •Any patient whose doctor considers that he will not be able to comply with the obligations of the trial
- •Patients under curatorship or tutorship
- •Pregnant women
研究组 & 干预措施
Patients
Patients
干预措施: collection of clinical parameters and blood sample (Other)
结局指标
主要结局
Percentage of patients who have agreed to receive SubCutaneous (SC) REMSIMA® and who continued this treatment for at least 6 months.
时间窗: Month 6
Therapeutic maintenance of SC REMSIMA® at 6 months, defined by the percentage of patients who have agreed to receive SC REMSIMA® and who continued this treatment for at least 6 months.
次要结局
- Number of patients who requested to be re-established on intravenous(IV) infliximab(Month 3)
- Percentage of positive ADA(Month 12)
- Percentage of patients switching or not switching to remsima® SC(Day 0)
- Number of patients who requested to be re-established on iv infliximab(Month 12)
- Questionnaire about reasons explaining the missing of a scheduled Remsina injection(Month 12)
- Number of sc remsima® discontinuation(Month 12)
- Questionnaire about reasons explaining Remsina discontinuation(Month 12)
- Number of missing SC injections(Month 12)
- Frequencies of serious adverse effects(Month 12)
- Infliximab trough levels(Month 12)
- Presence or absence of inflammatory flare since the last infusion(Month 12)
- Number of flares of disease(Month 12)
- Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)(Month 12)
- Scale of global appreciation of the activity (by the patient)(Month 12)
- Scale of global appreciation of the activity (by the investigator)(Month 12)
- Number of swollen/painful joints (Rheumatoid arthritis patient)(Month 12)
- Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)(Month 12)
- BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)(Month 12)
- Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)(Month 12)
- Number of patients who requested to be re-established on iv infliximab(Month 6)
- Number of sc remsima® discontinuation(Month 3)
- Questionnaire about reasons explaining Remsina discontinuation(Month 3)
- Number of sc remsima® discontinuation(Month 6)
- Questionnaire about reasons explaining Remsina discontinuation(Month 6)
- Number of missing SC injections(Month 3)
- Questionnaire about reasons explaining the missing of a scheduled Remsina injection(Month 3)
- Number of missing SC injections(Month 6)
- Questionnaire about reasons explaining the missing of a scheduled Remsina injection(Month 6)
- Frequencies of serious adverse effects(Month 3)
- Frequencies of serious adverse effects(Month 6)
- Percentage of positive ADA(Month 6)
- Infliximab trough levels(Month 6)
- Presence or absence of inflammatory flare since the last infusion(Month 3)
- Presence or absence of inflammatory flare since the last infusion(Month 6)
- Number of flares of disease(Month 3)
- Number of flares of disease(Month 6)
- Scale of global appreciation of the activity (by the patient)(Month 3)
- Scale of global appreciation of the activity (by the patient)(Month 6)
- Scale of global appreciation of the activity (by the investigator)(Month 3)
- Scale of global appreciation of the activity (by the investigator)(Month 6)
- Number of swollen/painful joints (Rheumatoid arthritis patient)(Month 3)
- Number of swollen/painful joints (Rheumatoid arthritis patient)(Month 6)
- Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)(Month 3)
- Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)(Month 6)
- Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)(Month 3)
- Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)(Month 6)
- BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)(Month 3)
- BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)(Month 6)
- Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)(Month 3)
- Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)(Month 6)