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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SinnoTest® software | Experimental | 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. |
|
| Patient Current care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotherapy Prescription with SinnoTest® software | Diagnostic Test | The rheumatologist will use the SinnoTest® software to give the best biotherapy to the patient according to the results of the software. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe GAUDIN, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens | Amiens | France | ||||
| CHU J Minjoz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29885551 | Background | Nguyen MVC, Baillet A, Romand X, Trocme C, Courtier A, Marotte H, Thomas T, Soubrier M, Miossec P, Tebib J, Grange L, Toussaint B, Lequerre T, Vittecoq O, Gaudin P. Prealbumin, platelet factor 4 and S100A12 combination at baseline predicts good response to TNF alpha inhibitors in rheumatoid arthritis. Joint Bone Spine. 2019 Mar;86(2):195-201. doi: 10.1016/j.jbspin.2018.05.006. Epub 2018 Jun 6. | |
| 30243783 |
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Prospective clinical trial, phase III, randomized in 2 parallel groups, multicentric, controlled (prescription with SinnoTest® software versus prescription without SinnoTest® software), single-blind
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The patient will not know if his bDMARD treatment was prescribed with or without the help of SinnoTest® software
| Patient Current Care | Drug | The rheumatologist will use the french guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient. |
|
|
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 |
| 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 |
| APHP Groupe hospitalier Pitié-Salpêtrière | Paris | France |
| APHP Hôpital Cochin | Paris | France |
| CHU Rouen Hôpital bois-guillaume | Rouen | France |
| CHU Saint-Etienne | Saint-Etienne | France |
| CHU Strasbourg Hôpital HAUTEPIERRE | Strasbourg | France |
| Hôpital PURPAN | Toulouse | France |
| Background |
| Nguyen MVC, Adrait A, Baillet A, Trocme C, Gottenberg JE, Gaudin P. Identification of cartilage oligomeric matrix protein as biomarker predicting abatacept response in rheumatoid arthritis patients with insufficient response to a first anti-TNFalpha treatment. Joint Bone Spine. 2019 May;86(3):401-403. doi: 10.1016/j.jbspin.2018.09.005. Epub 2018 Sep 19. No abstract available. |
| 30919904 | Background | Baillet A, Trocme C, Romand X, Nguyen CMV, Courtier A, Toussaint B, Gaudin P, Epaulard O. Calprotectin discriminates septic arthritis from pseudogout and rheumatoid arthritis. Rheumatology (Oxford). 2019 Sep 1;58(9):1644-1648. doi: 10.1093/rheumatology/kez098. |
| 20100792 | Background | Baillet A, Trocme C, Berthier S, Arlotto M, Grange L, Chenau J, Quetant S, Seve M, Berger F, Juvin R, Morel F, Gaudin P. Synovial fluid proteomic fingerprint: S100A8, S100A9 and S100A12 proteins discriminate rheumatoid arthritis from other inflammatory joint diseases. Rheumatology (Oxford). 2010 Apr;49(4):671-82. doi: 10.1093/rheumatology/kep452. Epub 2010 Jan 25. |
| 18664547 | Background | Trocme C, Marotte H, Baillet A, Pallot-Prades B, Garin J, Grange L, Miossec P, Tebib J, Berger F, Nissen MJ, Juvin R, Morel F, Gaudin P. Apolipoprotein A-I and platelet factor 4 are biomarkers for infliximab response in rheumatoid arthritis. Ann Rheum Dis. 2009 Aug;68(8):1328-33. doi: 10.1136/ard.2008.093153. Epub 2008 Jul 29. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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