Status:
UNKNOWN
Effect of Controlling Environmental Risk Factors in Established RA
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
* The factors contributing to the development of rheumatoid arthritis are multiple, with a role of the environment and a predisposing genetic background. * Among the modifiable environmental factors :...
Detailed Description
Methodology: * We will conduct a Phase 2 to one phase trial with A'Hern design. * The patients included will have RA (ACR / EULAR 2010 criteria), with an active disease (2.6 \<DAS 28 \<5.1), and at l...
Eligibility Criteria
Inclusion
- RA (ACR / EULAR 2010 criteria), with an active disease (2.6 \<DAS 28 \<5.1)
- Basis treatment for at least 3 months and corticoids \<= 10mg / day
- And at least 3 risk factors among:
- BMI ≥25 kg / m²
- Low physical activity (IPAQ short version)
- Active smoking
- Periodontitis ( bone loss on dental panoramic)
- Anxiety ( Beck anxiety Index \> 16)
Exclusion
- Patient under protective measure or unable to consent
- Patient for whom a change in basic treatment for RA is planned within 6 months
- Active cancer
- Active infection
- Antibiotic therapy in the previous 3 months
- No health cover
- Diabetes
- Unbalanced psychiatric pathologies
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05198271
Start Date
May 31 2022
End Date
January 1 2025
Last Update
September 8 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295