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

Grenoble Alpes University Hospital Center (CHU)

Status: Withdrawn

Conditions: Biological Therapy; Arthritis, Rheumatoid

Treatments: Drug: Patient Current Care; Diagnostic Test: Biotherapy Prescription with SinnoTest® software

Study type: Interventional

Funder types: Other

Identifiers

NCT04117165

2019-A01709-48

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

SinnoTest® software

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Biotherapy Prescription with SinnoTest® software

Patient Current care

Active Comparator group

Description:

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.

Treatment:

Drug: Patient Current Care