Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 16
- 主要终点
- Clinical benefit of using SinnoTest® software at 6 months
研究概览
简要总结
Rheumatoid arthritis (RA) is one of the main chronic inflammatory rheumatic diseases (RCI), with a prevalence of about 0.4% of the population.
First-line treatment with immunomodulators (synthetic and biological Disease Modifying Anti-Rheumatic Drugs (sDMARDs) including methotrexate) is not sufficiently effective in 40% of cases. These patients are then treated with biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) called biotherapies. As the use of these bio-drugs increases each year, they become a major public health and economic issue. Their growth is only just beginning, as they are among the major providers of pharmaceutical innovation.
There are about ten bio-drugs currently on the market for rheumatoid arthritis with an average annual treatment cost of 8 to 12 000 euros per patient. This cost is 20 times higher than that of sDMARDs. However, among patients treated with biotherapy, clinical practice shows that approximately one-third (33%) will not respond to the selected bio-drugs.
In the event of non-response, physicians currently have no choice but to rotate empirically between different treatments, as no tools capable of predicting response or non-response to these molecules are currently available. SinnoTest® software, a predictive algorithm for responding to bDMARDs by analyzing proteomic biomarkers, will clarify this choice of prescription for patients with failed RA of a first bDMARD in the anti-TNF family.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The patient will not know if his bDMARD treatment was prescribed with or without the help of SinnoTest® software
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Rheumatoid Arthritis defined according to ACR/EULAR 2010 or ACR 1987 criteria.
- •Patients in failure (patient insufficiently responding to anti-TNF treatment DAS28 > 3.2 whether related to primary biotherapy failure, loss of efficacy (loss of response) or adverse event) of a first bDMARD of the anti-TNF family (Adalimumab, Infliximab, Etanercept, Certolizumab or Golimumab).
- •Stability of synthetic fund processing for 3 months.
- •Corticosteroids ≤ 0.1 mg/kg/day without cortisone assault within 3 months.
- •Effective contraception for patients with reproductive capacity (oral contraceptive, intrauterine device, implant, surgical sterilization or abstinence).
- •Patients who have dated and signed the consent form for the trial.
- •Patients affiliated to a social security system.
排除标准
- •Contraindication to at least one of the following bDMARDs: Rituximab and/or Abatacept and/or Adalimumab.
- •Scheduled surgical intervention during the trial.
- •Difficulties in understanding the French language.
- •Cognitive function disorders (dementia such as Alzheimer's, etc.).
- •Patients who cannot be followed up at 12 months.
- •Psycho-social instability incompatible with regular follow-up (homelessness, addictive behavior, a history of psychiatric pathology or any other comorbidity that would make free and informed consent impossible or limit adherence to the protocol).
- •Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
- •Patients currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.
研究组 & 干预措施
SinnoTest® software
SinnoTest® is a therapeutic guidance device for patients suffering from chronic inflammatory rheumatism, in particular, rheumatoid arthritis. Prescription of bDMARD or their biosimilars is possible.
干预措施: Biotherapy Prescription with SinnoTest® software (Diagnostic Test)
Patient Current care
Current care of patients with rheumatoid arthritis, based on the recommendations of the French Society of Rheumatology. Prescription of bDMARD or their biosimilars is possible.
干预措施: Patient Current Care (Drug)
结局指标
主要结局
Clinical benefit of using SinnoTest® software at 6 months
时间窗: 6 months
Clinical benefit of using SinnoTest® software in patients with RA who have failed to respond to a bDMARD of the anti-TNF family compared to usual care practice
次要结局
- Cost-utility analysis that will compare the 2 groups at 1 year from the community's perspective.(1 year)
- Performance of the software predictive model on the new clinical data from the trial at 6 months and 1 year(6 months and 1 year)
- Cost-effectiveness analysis that will compare the group with SinnoTest® compared to the group without SinnoTest®, at 1 year from the community's point of view.(1 year)
- Comparison of the variation in the proteomic profile between M0 (biotherapy start date) and M6(Inclusion and 6 months)
- Clinical benefit of using SinnoTest® software at 1 year(1 year)
- Comparison of the response delay to a bDMARD and the number of bDMARDs prescribed during 12 months in both arms.(1 year)
- Budget impact analysis from the point of view of Health Insurance at 3 and 5 years.(3 and 5 years)