Status:
ACTIVE_NOT_RECRUITING
Performance of PEAR 2.0 Software in Prescribing Biotherapy in Patients With Rheumatoid Arthritis
Lead Sponsor:
CEN Biotech
Collaborating Sponsors:
MYEXPRESION
Conditions:
Polyarthritis; Rheumatoid
Eligibility:
All Genders
18+ years
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 (meth...
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 obj...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT06186375
Start Date
May 5 2023
End Date
March 31 2026
Last Update
August 6 2025
Active Locations (4)
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1
University Hospital of DIJON
Dijon, France, 21000
2
Hôpital Roger Salengro University Hospital of Lille
Lille, France, 59037
3
Hospital of Orleans
Orléans, France, 45100
4
University Hospital of Saint-Etienne
Saint-Priest-en-Jarez, France, 42270