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

NCT06186375 | Active Not Recruiting

• 1 other identifier: C1708
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 4

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.

Conditions

Polyarthritis; Rheumatoid

Keywords

prescription-assistance software

Outcome Measures

Primary Outcomes (1)

• Prediction of the Individualized Therapeutic Information Report (RITI)

  Concordance rate (Kappa) between responder/non-responder rates to biotherapy (actual result) and those predicted by the RITI orientation score (theoretical result). A responder to the prescribed biotherapy is a patient in remission 6 months after initiation of treatment. Clinical and biological remission is defined as a DAS 28 (Disease Activity Score) \< 2.6.

  6 months

Secondary Outcomes (2)

• Determinants of biotherapy choice

  Day 0

• Opinion of the investigator on RITI

  6 months

Study Arms (1)

Patients' study

Patient with planned biotherapy

Other: Patients with planned biotherapy

Interventions

Patients with planned biotherapy OTHER

Single additional volume of blood (10 ml) to be collected using the PAXgene system at the same time as the routine blood test before starting biotherapy.

Patients' study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in rheumatology hospital wards

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CEN Biotech: lead
• MYEXPRESION: collaborator

Study Sites (4)

University Hospital of DIJON

Dijon, 21000, France

Location

Hôpital Roger Salengro University Hospital of Lille

Lille, 59037, France

Location

Hospital of Orleans

Orléans, 45100, France

Location

University Hospital of Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for transcriptome analysis

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 2, 2024
• Study Start: May 5, 2023
• Primary Completion: November 30, 2025
• Study Completion: March 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

FR (4)