Performance of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis

CEN Biotech

Status

Active, not recruiting

Conditions

Polyarthritis; Rheumatoid

Treatments

Other: Patients with planned biotherapy

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT06186375

C1708

Details and patient eligibility

About

The management of rheumatoid arthritis is based on the prescription of disease-modifying anti-rheumatic drugs (DMARDs) to induce clinical and biological remission. If the first line of treatment (methotrexate) fails, a biotherapy may be prescribed. In daily practice, the initiation of a targeted therapy must therefore be based on the prescriber's expertise or qualification in terms of his or her level of experience in the diagnosis and management of chronic inflammatory rheumatic diseases such as rheumatoid arthritis. As the therapeutic arsenal has expanded, so has the question of choosing the right treatment for the right patient at the right time. At present, in daily practice, there is no tool to help clinicians predict treatment efficacy. The choice of biotherapy based on efficacy carries relatively little weight, firstly because this choice is made in relation to other biotherapies, and secondly because there are no superiority studies that have actually demonstrated greater efficacy in favor of one of the targeted therapies. In the age of Big Data, artificial intelligence can be used to develop algorithms for predicting treatment response. mYXpression has developed medical decision support software based on the integration of transcriptomic markers to assess the probability of response and/or non-response to biotherapies for each patient. The algorithm's performance was theoretically tested by retrospectively collecting transcriptomic data and clinical responses to 6 biotherapies from 992 patients included in 17 clinical trials or cohorts. The aim of this observational study is to demonstrate the value of PEAR 2.0 medical decision support software in the management of rheumatoid arthritis patients who are candidates for biotherapy.

Full description

This study plans to include 234 patients who, like you, suffer from rheumatoid arthritis, and who will initiate biotherapy in one of the hospital departments taking part in this research. The main objective is to demonstrate the performance of the PEAR 2.0 decision support software, i.e. to show that the software's recommendations for achieving remission are accurate and reliable. The other objectives are to collect data that could help the algorithm evolve, and to provide other information such as the probability of achieving a reduction in rheumatoid arthritis activity in patients who have failed several biotherapies.

Because the software must first demonstrate its reliability, the investigator will not use it and will prescribe the biotherapy he thinks is best suited to his patient. The software's results will be communicated to the investigator at the consultation scheduled 6 months after the start of the biotherapy.

During two consultations (before the start of biotherapy and 6 months after the first day of biotherapy), the investigator will collect the data needed for the study and which describe the disease. These data are either present in the patient's medical record or are usually collected during consultations in the rheumatology department.

For the purposes of the study, at the first visit, the investigator will prescribe a blood sample (10 ml) to be taken at the hospital laboratory before starting the biotherapy. This sample will be used to analyze the biological markers (transcriptome) that the software algorithm uses to establish its recommendations.

Enrollment

239 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female 18 years or older ;
With severe rheumatoid arthritis (DAS 28 ≥ 5.1) or moderate rheumatoid arthritis (DAS 28 3.2 ≥ and <5.1);
For whom one of the 6 biotherapies Etanercept, Adalimumab, Infliximab, Rituximab, Tocilizumab, Abatacept, or respective biosimilars, is planned, and accepting treatment after having been duly informed of the risks and benefits of the biotherapy;
Agreeing to the collection of an additional volume of blood for transcriptomic analysis;
Having given their free, informed and express written consent;
Affiliated with a French social security scheme.

Exclusion criteria

Biotherapies not analyzed by RITI (Certolizumab, Golimumab, Anakinra, Sarilumab);
Combination of biotherapies or combination with a tsDMARD);
Patients under judicial protection (curatorship, guardianship, safeguard of justice) or patients with psychotic disorders unable to complete quality of life and assessment questionnaires;
Already included in an interventional study or in the exclusion period of an interventional study.