Effect of Controlling Environmental Risk Factors in Established RA

Rheumatoid Arthritis Clinical Trial

— DISRUPT-estRA  

Official title:

Effect of Controlling Environmental Risk Factors in Established RA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198271
• Other study ID #: RECHMPL21_0533
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: January 2025

Study information

• Verified date: September 2023
• Source: University Hospital, Montpellier
• Contact: Claire DAIEN, MD
• Phone: +33467337794
• Email: c-daien[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Management of risk factors
For all patients: Online dietician consultation (45 min 1st consultation with set objectives then 15-20 min for the following ones) then proposal of varied weekly menus, adapted to different cultural and social contexts by email and reassessment at M3 and M6 Clinical and radiographic periodontological evaluation at M0 and M6 by a specialist with dental hygiene advice with delivery of equipment and scaling Initial teleconsultation with motivational interview by sports doctor / APA (30 min) with evaluation of initial physical activity, search for contraindications and development of a personalized program with aerobic and resistance training. Provision of filmed sessions and digital exercise materials for regular practice at home and self-assessment using data from the accelerometer with automatic online report. Motivational supports on the MyGoodLife / MyGoodCare platform (weight, food questionnaire, pedometer, tobacco consumption)

Behavioral:
• Smoking cessation
- For active smoking patients: Tobacco consultations: S0, S4 and S8 then according to the opinion of the tobacco specialist Nicotine substitutes +/- varenicline according to tobacco consumption Online notebook to record tobacco consumption and "triggers"
• weightloss
-For overweight or obese patients: Online dietician consultation every 15 days for 3 months, the consultation based on the online filling of food questionnaires and the weight curve

Other:
• periodontal disease treatment
- For patients with periodontal disease: treatment of periodontal disease (planing, cast splint, tooth avulsion, etc.) between M0 and M3, dental panoramic M0 at inclusion and M6

Behavioral:
• increased physical activity
- For patients with low physical activity: Follow-up by level gp session: 45 '/ week for 3 months
• Decreased anxiety
- For anxious patients: Teleconsultation with a psychiatrist specializing in stress management, global assessment, identification of the factors involved and training in the use of cardiac coherence Delivery of connected equipment for the practice of cardiac coherence

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the effectiveness at 6 months of this program on the overall reduction / correction of risk factors.	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 correction.; Risk factors will be considered corrected / in the process of being corrected if: Weight loss =5% of initial weight at 6 months (objective measurement of weight) and / or BMI at 6 months < 25kg/m²; Complete smoking cessation (declarative assessment); Correction of sedentary lifestyle with moderate to strong IPAQ AND increase of =2,000 steps / day compared to the initial assessment (on average 5 days / 7) (questionnaire and quantified assessment obtained with the pedometer and automatically reported on the platform); Improvement in periodontal disease scores =4 points on 6 teeth assessed according to Ramfjord's recommendation (plaque index (Sillness and Loe index), gingival (Lobene index) and papillary bleeding index) (evaluation by the periodontologist); Decrease in anxiety score from N class to N-1 class	6 MONTHS
Secondary	To assess the acceptability and adherence of RA patients to the intervention program.	Acceptability: number of patients agreeing to participate in the protocol / total number of screened patients fulfilling the inclusion criteria.; questionnaire with different visual analog scales carried out at the end of the program.; Adherence: assessed by completing online questionnaires / weight, using the accelerometer, participating in various teleconsultations and organized group sessions	6 MONTHS
Secondary	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.	same description as for the outcome 1	3 MONTHS
Secondary	RA activity	DAS 28-CRP, RAID, biological markers (FR, ACPA, CRP)	3 MONTHS, 6 MONTHS
Secondary	Distribution of the different germs of the oral and fecal micobiota and alpha and beta diversity	targeted metagenomics 16s RNA	3 MONTHS, 6 MONTHS
Secondary	Personality traits assessed by the Minnesota Multiphasic Personality Inventory questionnaire (MMPI)		MONTH 0