BElimumab corticoSteroids Sparing Treatment in Systemic Lupus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- number of patients whith low dose of steroids at six months after BELIMUMAB
研究概览
简要总结
BELIMUMAB, anti-BLyS human monoclonal antibody, is the first immunotherapy used for the treatment of systemic lupus erythematosus (SLE) which was licensed in 2011 in France.
Currently, Belimumab is reimbursed for the treatment of active SLEwith autoantibody-positive after intolerant or initial failure of first-line traitment (anti malaria, non-steroidal anti-inflammatory drugs, glucocorticoids and/ou immunomodulatory agents).
EUropean League Against Rheumatism (EULAR) suggest the following terminology of "low dose" when steroids are less than 7.5 mg/day (prednisone equivalent) because this dose range is often used for maintenance therapy for many rheumatic diseases requiring glucocorticoids and it is relatively few adverse effects.
In patients with SLE, a significant proportion of the damage could be attributed to corticosteroid therapy, and this damage accumulated over time.
Thanks to randomised and subgroups trials, post-hoc analysis , BELIMUMAB seems to be interesting in the maintain of lowest possible dose of glucocorticoids. However, these studies were not design with this aim, so it is impossible to conclude.
Thus, BELIMUMAB seems to be very interesting treatment to redcuce glucocorticoids level.
We conduce a multicentric French study in real-life settings, to assess the ability of belimumab to achieve low-dose of steroids.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •person aged ≥ 18 years
- •with SLE according to ACR/EULAR criteria 2019
- •started treatment by BELIMUMAB between 13 / July / 2011 to 13 / July / 2020
- •following in an hospital center in Poitiers, La Rochelle, Rochefort, Niort, Angoulême, Nantes, Rennes, Tours, Angers
- •affiliate or beneficiary of a social security scheme
排除标准
- •Persons Under guardianship or curatorship or without civil law
- •Pregnant and breastfeeding
- •Persons who refused to participate
- •Patients who stoppped BELIMUMAB before 6 months
结局指标
主要结局
number of patients whith low dose of steroids at six months after BELIMUMAB
时间窗: at six months after BELIMUMAB
number of patients whith low dose of steroids at six months after BELIMUMAB
次要结局
- number of patients whith low dose of steroids at 12, 18 and 24 months after BELIMUMAB(12, 18 and 24 months after BELIMUMAB)
- cumulative dose of steroids at 6, 12, 18, 24 months(6, 12, 18, 24 months)
研究者
Perier
Doctor
Centre Hospitalier de Niort