Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis
NCT ID: NCT04117165
Last Updated: 2021-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-03-01
2023-09-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Biotherapy Prescription with SinnoTest® software
The rheumatologist will use the SinnoTest® software to give the best biotherapy to the patient according to the results of the software.
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.
Patient Current Care
The rheumatologist will use the french guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient.
Interventions
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Biotherapy Prescription with SinnoTest® software
The rheumatologist will use the SinnoTest® software to give the best biotherapy to the patient according to the results of the software.
Patient Current Care
The rheumatologist will use the french guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Philippe GAUDIN, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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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
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
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2019-A01709-48
Identifier Type: -
Identifier Source: org_study_id
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