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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
The rheumatologist will use the SinnoTest® software to give the best biotherapy to the patient according to the results of the software.
The rheumatologist will use the french guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient.
Chu Amiens
Amiens, France
CHU J Minjoz
Besançon, France
Groupe Hospitalier Pellegrin - CHU de Bordeaux
Bordeaux, France
CHU Cavale Blanche
Brest, France
Clinique de l'infirmerie protestante
Caluire-et-Cuire, France
Hôpital G. Montpied
Clermont-Ferrand, France
CHU DIJON Hôpital le Bocage
Dijon, France
Grenoble University Hospital
Grenoble, France
CHU Montpellier Hôpital Lapeyronie
Montpellier, France
CHU NANTES - Hôtel Dieu
Nantes, France
...and 6 more locations
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
Time frame: 6 months
Clinical benefit of using SinnoTest® software at 1 year
Patients who respond according to the disease activity criteria from the DAS28 scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 3 and 5 years
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