Clinical trial NCT05198271: Effect of Controlling Environmental Risk Factors in Established RA
Official title: Effect of Controlling Environmental Risk Factors in Established RA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: prevention
smoking
diet
periodontitis
physical activity
stress
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 :unbalanced diet, overweight, low physical activity, smoking, periodontal disease, stress have been identified as risk factors for developing RA.
* By causing low-grade inflammation and stimulation of the immune system (particularly through adipokines, citrullination phenomena and changes in the microbiota), these factors promote the onset of the disease and could also participate in the maintenance of inflammatory processes.
* Thus, obese subjects have more active RA, a lower therapeutic response, and weight loss is associated with lower disease activity ; sedentary lifestyle is associated with more active RA and increased physical activity has beneficial effects on RA; people who smoke respond less well to treatment; periodontal disease is associated with more active RA and their treatment is associated with a decrease in this activity.
* Finally, different methods having a beneficial impact on stress (mindfulness meditation, yoga, relaxation, etc.) have shown interesting results in patients with RA.
* It is important to note that all of these factors are also associated with an increased cardiovascular risk, the leading cause of death in RA.
* The combination of these factors probably has synergistic effects and it is therefore relevant to propose a correction of all these factors in the same program.
* We have developed a management program for environmental risk factors for RA based with experts including rheumatologists, nutritionists, smoking cessation specialists, periodontal disease specialists and stress specialists.

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 least 3 risk factors among: BMI ≥25 kg / m², low physical activity , active smoking, periodontitis and anxiety.

  1. The primary endpoint will be the number of patients for whom at least 2 or 3 risk factors (depending on whether 3 present or 4-5 present at baseline) are corrected / in the process of being corrected at 6 months.
  2. The secondary endpoints will be:

A) Acceptability: number of patients agreeing to participate in the protocol / total number of screened patients fulfilling the inclusion criteria; questionnaires with EVA carried out at the end of the program; Membership of the program: online completion of questionnaires, use of the accelerometer, participation in teleconsultations and organized group sessions.

B) For each risk factors: number of patients who corrected it at 3 and 6 months.

C) RA activity measured by DAS28-CRP + RAID questionnaire, biological markers

D) Distribution of the different germs of the oral and faecal micobiota and diversity.

* As risks factor are established chronically, we hypothesize that only 10% of patients would correct at least 2 or 3 risk factors over 6 months in the absence of intervention. The expected efficiency is 40%.
* By recruiting 25 patients, we will have a power of 90% to demonstrate that the one-sided 95% confidence interval of the effectiveness of the intervention is greater than 10% (p (0) if the true value of effectiveness is 35% (p (1)). This demonstration will be made if 6 patients out of 25 are successful.

Procedure:

* 3 visits will be necessary for rheumatological and biological evaluations (inclusion +/- M0, M3 and M6).
* All patients will have 2 periodontal visits (M0 and M6 for evaluation and scaling). Those with periodontitis will have other visits depending on the care to be performed.
* The smoking patients will have teleconsultations (TC) with a tobacco specialist (S0, S4 and S8 then according to tobacco specialist).
* All patients will have a TC with a dietitian (45 min 1st consultation with set goals) and those overweight will then have a TC every 15 days for 3 months.
* All patients will have a TC with a sports doctor (assessment of physical activity and development of a personalized program, explanation of the pedometer provided). For those with low physical activity, a virtual group session of 45 min / week will be organized.
* Patients with anxiety will have TC with a psychiatrist specializing in stress management, with training in the use of cardiac coherence from connected equipment given to the patient.
* All the interventions will be coordinated on an existing platform (MyGoodLife) which allows the dietary assessment, the automatic report of connected objects (pedometer) and the organization of group sessions.

Eligibility 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

Primary outcomes:
measure: Estimate the effectiveness at 6 months of this program on the overall reduction / correction of risk factors.
timeFrame: 6 MONTHS
Secondary outcomes:
measure: To assess the acceptability and adherence of RA patients to the intervention program.
timeFrame: 6 MONTHS
measure: At least two risk factors (if 3 present at base) or at least three (if 4 or 5 present at base) are corrected / in the process of correction.
timeFrame: 3 MONTHS
measure: RA activity
timeFrame: 3 MONTHS, 6 MONTHS
measure: Distribution of the different germs of the oral and fecal micobiota and alpha and beta diversity
timeFrame: 3 MONTHS, 6 MONTHS
measure: Personality traits assessed by the Minnesota Multiphasic Personality Inventory questionnaire (MMPI)
timeFrame: MONTH 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
Study officials:
affiliation: UH of Montpellier
name: Claire DAIEN, MD
role: STUDY_DIRECTOR
References: