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

Arthritis, Rheumatoid Clinical Trial

— SINNO-RA  

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04117165
• Other study ID #: 2019-A01709-48
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Biological Therapy

Intervention

Diagnostic Test:
• 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.

Drug:
• Patient Current Care
The rheumatologist will use the french guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient.

Locations

Country	Name	City	State
France	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-Étienne
France	CHU Strasbourg Hôpital HAUTEPIERRE	Strasbourg
France	Hôpital PURPAN	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

Baillet A, Trocmé C, Berthier S, Arlotto M, Grange L, Chenau J, Quétant S, Sève 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. — View Citation

Baillet A, Trocmé 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. — View Citation

Nguyen MVC, Adrait A, Baillet A, Trocmé 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-TNFa treatment. Joint Bone Spine. 2019 May;86(3):401-403. doi: 10.1016/j.jbspin.2018.09.005. Epub 2018 Sep 19. — View Citation

Nguyen MVC, Baillet A, Romand X, Trocmé C, Courtier A, Marotte H, Thomas T, Soubrier M, Miossec P, Tébib J, Grange L, Toussaint B, Lequerré 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. — View Citation

Trocmé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical benefit of using SinnoTest® software at 1 year	Patients who respond according to the disease activity criteria from the DAS28 scale	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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