PRediction mEdical DevIce for Rheumatoid Arthritis: Scale-up of Unique Predictive Online Platform Highly Improving the Quality of Life of Rheumatoid Arthritis' Patient by Personalised and Efficient Biotherapies Prescription
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 10
- 主要终点
- Incremental Cost Utility ratio at 6 months
研究概览
简要总结
Rheumatoid arthritis (RA) is one of the leading chronic inflammatory rheumatism, with a prevalence of about 0.4% of the population.
First-line therapy with synthetic disease modifying anti-rheumatic drugs (including methotrexate) is insufficiently effective in 40% of cases. These patients are then treated with biotherapies. The use of these bio-drugs increases each year, becoming a public health issue and a considerable economic burden. Besides, their growth is just beginning, as they are among the major purveyors of pharmacy innovations.
There are about ten bio-drugs currently on the market for rheumatoid arthritis with an average annual treatment cost of 8 to 12 K € per patient. This cost is 20 times higher than that of synthetic disease modifying anti-rheumatic drugs. However, among patients treated with biotherapies, clinical practice shows that about one-third will not respond to the selected drug. In the case of non-response, practitioners currently have no choice but to perform an empirical rotation between the different treatments, because no tool capable of predicting the response or non-response to these molecules is currently available.
The study is a prospective, phase III, controlled, multicenter, and randomized, single-blind (patient) clinical trial.
- Intervention arm: Prescription of biotherapy (rituximab, adalimumab, abatacept) using SinnoTest® software
- Control arm: Prescription of biotherapy without the SinnoTest® software which corresponds to current practice (all biotherapies).
In addition, a sub study will be carried out within this trial to analyse the proteomic profile of the patients included and their modification throughout the study.
To study the clinical and pharmacoeconomic impact after 6 months of the use of the SinnoTest® predictive tool in patients with rheumatoid arthritis who have failed to a first anti-TNF biologic agent compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 over 18 years old and under 70 years old,
- •Patients with RA, defined according to the ACR / EULAR 2010 or ACR 1987 criteria,
- •Patients failing a first anti-TNF, defined as:
- •Ineffectiveness (which is defined as a DAS28-ESR ≥3.2 and an inadequate response to iTNF according to the usual rheumatologist, which generally includes one or more of the following conditions: persistent swollen and tender joints, persistence of disease activity according to the overall evaluation of the patient, high levels of acute phase reactants and/or dependence of analgesics, nonsteroidal anti-inflammatory drugs or corticosteroids); or
- •Toxicity(defined as the appearance of any adverse event that the patient's rheumatologist relates to the medication and requires discontinuation),
- •Effective contraception for patients of childbearing potential (oral contraceptive, intrauterine device, implant, spermicide, surgical sterilization or abstinence),
- •Patients able to read and understand the modalities of the protocol,
- •Patients who have dated and signed the informed consent form of the trial,
- •Stability of treatments (no change) between the selection visit and the inclusion visit (M0).
排除标准
- •Patients with a contraindication to any bDMARD or methotrexate,
- •Patients included in another therapeutic evaluation study during this trial,
- •Surgical intervention programmed during the trial,
- •Patients with difficulties in understanding the Spanish language,
- •Patients cannot be followed up 6 months,
- •Psychosocial instability incompatible with regular monitoring (homelessness, addictive behaviour, antecedent of psychiatric pathology or any other comorbidity that would make it impossible for free and informed consent or limit adherence to the protocol),
- •Breastfeeding and/or pregnancy. Although there are bDMARD that can be used in pregnancy, since SinnoTest can recommend one that discourages this condition, it is decided to exclude the inclusion of pregnant women.
结局指标
主要结局
Incremental Cost Utility ratio at 6 months
时间窗: 6 months
This outcome will be calculated as the average differential cost per patient between both study arms (mean costs of the Sinnotest® Arm - mean costs of the Control Arm) divided by the diference in effectiveness between both study arms measured in the number of years of life weighted by the quality of life (QALY: quality-adjusted life year) generated by each of the strategies (mean QALY of the Sinnotest® Arm - mean QALY of the Control Arm). QALY will be measured using the EuroQol-5D. Cost will be considered from a Societal perspective, including both direct and indirect costs The ratio will be expressed in cost (2019 Euros) per QALY earned, which represents the additional cost that will have to be spent to earn a healthy year of life
次要结局
- Budget impact analysis at 6 and 12 months(12 months)
- Description of the variation of the proteomic profile between M0 (biotherapy start date) and M6 (6 months visit)(Inclusion and 6 months)
- Software's predictive model performance(6 months)
研究者
Benjamin Fernandez Gutierrez
Principal Investigator
Hospital San Carlos, Madrid