NCT06186375Active, not recruiting
Performance of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis
Performance Study of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 6 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 239 (actual)
- First submitted
- 13 Dec 2023
- Start date
- 5 May 2023
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- CEN Biotech
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06186375
What you commit to
- Study type: Observational
- Participants enrolled: 239
- From 5 May 2023 to the primary completion date, 30 Nov 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients under judicial protection (curatorship, guardianship, safeguard of justice) or patients with psychotic disorders unable to complete quality of life and assessment questionnaires;
Other
- Biotherapies not analyzed by RITI (Certolizumab, Golimumab, Anakinra, Sarilumab);
- Combination of biotherapies or combination with a tsDMARD);
- Already included in an interventional study or in the exclusion period of an interventional study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Dijon Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Hôpital Roger Salengro University Hospital of Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hospital of Orleans Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| University Hospital of Saint-Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.