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

Not Applicable

Withdrawn

• Conditions: Biological Therapy; Arthritis, Rheumatoid
• Interventions: Diagnostic Test: Biotherapy Prescription with SinnoTest® software; Drug: Patient Current Care

• Registration Number: NCT04117165
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-07
• Study Start: 2021-03-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-03
• Primary Completion: 2022-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SinnoTest® software	Biotherapy Prescription with 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.
Patient Current care	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.

Primary Outcome Measures

Name	Time	Method
Clinical benefit of using SinnoTest® software at 6 months	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

Secondary Outcome Measures

Name	Time	Method
Comparison of the variation in the proteomic profile between M0 (biotherapy start date) and M6	Inclusion and 6 months	Determination of the blood proteomic profile
Cost-utility analysis that will compare the 2 groups at 1 year from the community's perspective.	1 year	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
Performance of the software predictive model on the new clinical data from the trial at 6 months and 1 year	6 months and 1 year	Description of the properties of the prediction algorithms on the data of the study
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.	1 year	Incremental Cost-Effectiveness Ratio (ICER)
Clinical benefit of using SinnoTest® software at 1 year	1 year	Patients who respond according to the disease activity criteria from the DAS28 scale
Comparison of the response delay to a bDMARD and the number of bDMARDs prescribed during 12 months in both arms.	1 year	The delay and the number of bDMARDs prescribed before a good response
Budget impact analysis from the point of view of Health Insurance at 3 and 5 years.	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.

Trial Locations

Locations (16)

CHU J Minjoz; 🇫🇷 Besançon, France

Chu Amiens; 🇫🇷 Amiens, France

Clinique de l'infirmerie protestante; 🇫🇷 Caluire-et-Cuire, France

Groupe Hospitalier Pellegrin - CHU de Bordeaux; 🇫🇷 Bordeaux, France

CHU Cavale Blanche; 🇫🇷 Brest, France

Hôpital G. Montpied; 🇫🇷 Clermont-Ferrand, France

Grenoble University Hospital; 🇫🇷 Grenoble, France

CHU DIJON Hôpital le Bocage; 🇫🇷 Dijon, France

CHU Montpellier Hôpital Lapeyronie; 🇫🇷 Montpellier, France

APHP Groupe hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, France

CHU NANTES - Hôtel Dieu; 🇫🇷 Nantes, France

CHU Rouen Hôpital bois-guillaume; 🇫🇷 Rouen, France

APHP Hôpital Cochin; 🇫🇷 Paris, France

CHU Strasbourg Hôpital HAUTEPIERRE; 🇫🇷 Strasbourg, France

Hôpital PURPAN; 🇫🇷 Toulouse, France

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France