Status:
WITHDRAWN
Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Arthritis, Rheumatoid
Biological Therapy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Rheumatoid arthritis (RA) is one of the main chronic inflammatory rheumatic diseases (RCI), with a prevalence of about 0.4% of the population. First-line treatment with immunomodulators (synthetic an...
Eligibility Criteria
Inclusion
- Patients with Rheumatoid Arthritis defined according to ACR/EULAR 2010 or ACR 1987 criteria.
- Patients in failure (patient insufficiently responding to anti-TNF treatment DAS28 \> 3.2 whether related to primary biotherapy failure, loss of efficacy (loss of response) or adverse event) of a first bDMARD of the anti-TNF family (Adalimumab, Infliximab, Etanercept, Certolizumab or Golimumab).
- Stability of synthetic fund processing for 3 months.
- Corticosteroids ≤ 0.1 mg/kg/day without cortisone assault within 3 months.
- Effective contraception for patients with reproductive capacity (oral contraceptive, intrauterine device, implant, surgical sterilization or abstinence).
- Patients who have dated and signed the consent form for the trial.
- Patients affiliated to a social security system.
Exclusion
- Contraindication to at least one of the following bDMARDs: Rituximab and/or Abatacept and/or Adalimumab.
- Scheduled surgical intervention during the trial.
- Difficulties in understanding the French language.
- Cognitive function disorders (dementia such as Alzheimer's, etc.).
- Patients who cannot be followed up at 12 months.
- Psycho-social instability incompatible with regular follow-up (homelessness, addictive behavior, a history of psychiatric pathology or any other comorbidity that would make free and informed consent impossible or limit adherence to the protocol).
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
- Patients currently participating in other clinical research or who participated in a clinical trial within one month prior to inclusion.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04117165
Start Date
March 1 2021
End Date
September 1 2023
Last Update
May 3 2021
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu Amiens
Amiens, France
2
CHU J Minjoz
Besançon, France
3
Groupe Hospitalier Pellegrin - CHU de Bordeaux
Bordeaux, France
4
CHU Cavale Blanche
Brest, France