Performance Study of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis
Trial ID: NCT06186375
Status: ACTIVE_NOT_RECRUITING
Study type: OBSERVATIONAL
Start date: 2023-05-05
Completion date: 2026-03-31
Sponsor: CEN Biotech
Collaborators: MYEXPRESION
Conditions: Polyarthritis; Rheumatoid
Interventions: Patients with planned biotherapy
Locations: University Hospital of DIJON; Hôpital Roger Salengro University Hospital of Lille; Hospital of Orleans; University Hospital of Saint-Etienne
Countries: France; France; France; France
Enrollment: 239
Age range: 18 Years - None
Sex: ALL

Summary:
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.

Eligibility criteria:
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.

Outcomes:
Prediction of the Individualized Therapeutic Information Report (RITI)