Clinical trial NCT06186375: Performance of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis
Official title: Performance Study of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polyarthritis; Rheumatoid
Keywords: prescription-assistance software
Lead sponsor: CEN Biotech
Sponsor class: INDUSTRY
Collaborators: name: MYEXPRESION
First posted: 2024-01-02
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in rheumatology hospital wards

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Prediction of the Individualized Therapeutic Information Report (RITI)
timeFrame: 6 months
Secondary outcomes:
measure: Determinants of biotherapy choice
timeFrame: Day 0
measure: Opinion of the investigator on RITI
timeFrame: 6 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: University Hospital of DIJON
city: Lille
country: France
facility: Hôpital Roger Salengro University Hospital of Lille
city: Orleans
country: France
facility: Hospital of Orleans
city: Saint-priest-en-jarez
country: France
facility: University Hospital of Saint-Etienne
Study officials:
References: