Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Arthritis, Rheumatoid, Biological Therapy

Intervention / Treatment
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* Diagnostic Test: Biotherapy Prescription with SinnoTest® software
* Drug: Patient Current Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective clinical trial, phase III, randomized in 2 parallel groups, multicentric, controlled (prescription with SinnoTest® software versus prescription without SinnoTest® software), single-blind
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SinnoTest® software<br>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. | Diagnostic Test: Biotherapy Prescription with SinnoTest® software<br>* The rheumatologist will use the SinnoTest® software to give the best biotherapy to the patient according to the results of the software.<br>|
| Active Comparator: Patient Current care<br>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. | Drug: Patient Current Care<br>* The rheumatologist will use the french guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient.<br>* Other names: Biotherapy treatment without SinnoTest®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit of using SinnoTest® software at 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit of using SinnoTest® software at 1 year | Patients who respond according to the disease activity criteria from the DAS28 scale | 1 year | 
| Comparison of the response delay to a bDMARD and the number of bDMARDs prescribed during 12 months in both arms. | The delay and the number of bDMARDs prescribed before a good response | 1 year | 
| Performance of the software predictive model on the new clinical data from the trial at 6 months and 1 year | Description of the properties of the prediction algorithms on the data of the study | 6 months and 1 year | 
| Comparison of the variation in the proteomic profile between M0 (biotherapy start date) and M6 | Determination of the blood proteomic profile | Inclusion and 6 months | 
| Cost-utility analysis that will compare the 2 groups at 1 year from the community's perspective. | EuroQol five Dimensions questionnaire (EQ-5D-5L). The ratio will therefore be expressed as a cost per QALY earned, which represents the additional cost that will be required to earn a healthy year of life | 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. | Incremental Cost-Effectiveness Ratio (ICER) | 1 year | 
| Budget impact analysis from the point of view of Health Insurance at 3 and 5 years. | Measurement of the financial consequences for the Health Insurance of the implementation of SinnoTest® in the context of rheumatoid arthritis at 3- and 5-years' time point. | 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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predictive software, quality of life