Using PEAR 2.0 Software to Help Prescribe Biotherapy for Rheumatoid Arthritis
Performance Study of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis
This study is testing a new software called PEAR 2.0 to see if it can help doctors choose better biotherapy options for patients with rheumatoid arthritis who haven't responded to other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 234 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CEN Biotech Industry-sponsored |
| Drugs / interventions | Adalimumab, Infliximab, Rituximab, Tocilizumab, Certolizumab, Golimumab, Sarilumab, methotrexate |
| Locations | 4 sites (Dijon and 3 other locations) |
| Trial ID | NCT06186375 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of the PEAR 2.0 decision support software in prescribing biotherapy for patients with rheumatoid arthritis. It will include 234 patients who are starting biotherapy after failing previous treatments. The software's recommendations will be compared to the clinician's choices to assess its accuracy and reliability in achieving remission. Data will be collected through patient consultations and blood samples to enhance the software's algorithm and predict treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe or moderate rheumatoid arthritis who are about to start one of the specified biotherapies.
Not a fit: Patients who are not planning to start one of the analyzed biotherapies or those with certain psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this software could improve treatment outcomes for patients with rheumatoid arthritis by providing more accurate biotherapy recommendations.
How similar studies have performed: While the use of decision support software in treatment decisions is gaining traction, this specific approach with PEAR 2.0 is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dijon and 3 other locations
- University Hospital of DIJON — Dijon, France (Recruiting)
- Hôpital Roger Salengro University Hospital of Lille — Lille, France (Recruiting)
- Hospital of Orleans — Orleans, France (Recruiting)
- University Hospital of Saint-Etienne — Saint-priest-en-jarez, France (Recruiting)
Study contacts
- Study coordinator: Christine JUHEL, PHD
- Email: christine.juhel@groupecen.com
- Phone: +33380680511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.