Controlling environmental risk factors in rheumatoid arthritis
Effect of Controlling Environmental Risk Factors in Established RA
This study is testing if making changes like improving diet, increasing exercise, quitting smoking, and treating gum disease can help people with rheumatoid arthritis feel better and reduce their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05198271 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of managing environmental risk factors on patients with established rheumatoid arthritis (RA). It focuses on modifying factors such as diet, physical activity, smoking cessation, and treatment of periodontal disease to reduce disease activity. Patients with active RA and multiple risk factors will be recruited, and their progress will be monitored over six months to assess improvements in these risk factors and overall RA activity. The study employs a structured intervention approach and utilizes various endpoints to measure success.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with rheumatoid arthritis who have active disease and at least three identified risk factors.
Not a fit: Patients with uncontrolled comorbidities, such as active cancer or severe psychiatric disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of rheumatoid arthritis and better patient outcomes through lifestyle modifications.
How similar studies have performed: While there is existing literature on the impact of lifestyle changes on RA, this specific approach to controlling multiple environmental risk factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Montpellier
- Centre Hospitalier Universitaire de Montpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Claire DAIEN, MD
- Email: c-daien@chu-montpellier.fr
- Phone: +33467337794
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.