Rheumatoid ArthritisDISRUPT-estRANCT05198271
Effect of Controlling Environmental Risk Factors in Established RA
A study testing Management of risk factors, Smoking cessation and weightloss in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Management of risk factors, Smoking cessation and weightloss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2022to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Diabetes
- Unbalanced psychiatric pathologies
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
Claire DAIEN, MD, 04 67 33 77 94 ext. +33, c-daien@chu-montpellier.fr
About this study
- 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.
Read the 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.
- 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.
- The secondary endpoints will be:
- 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.
- For each risk factors: number of patients who corrected it at 3 and 6 months.
- RA activity measured by DAS28-CRP + RAID questionnaire, biological markers
- 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Management of risk factors, Smoking cessation, weightloss, periodontal disease treatment, increased physical activity
- Keywords
- prevention, smoking, diet, periodontitis, physical activity, stress
- Medical subject headings
- Arthritis, Rheumatoid, Smoking, Periodontitis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of risk factorsOther
- 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)
Smoking cessationBehavioural
- 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"
weightlossBehavioural
-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
periodontal disease treatmentOther
- 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
increased physical activityBehavioural
- For patients with low physical activity: Follow-up by level gp session: 45 '/ week for 3 months
Decreased anxietyBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Management of risk factors | Experimental | -6 month program for reduction /correction of risk factors in patient with active RA :
1. Smoking cessation
2. weightloss
3. Increased physical activity
4. Periodontal treatment
5. Decreased anxiety Receives: Other: Management of risk factors; Behavioral: Smoking cessation; Behavioral: weightloss; Other: periodontal disease treatment; Behavioral: increased physical activity; Behavioral: Decreased anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 MONTHS
Secondary outcomes (5)
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
Measured: 6 MONTHS
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
Measured: 3 MONTHS
RA activity
DAS 28-CRP, RAID, biological markers (FR, ACPA, CRP)
Measured: 3 MONTHS, 6 MONTHS
Distribution of the different germs of the oral and fecal micobiota and alpha and beta diversity
targeted metagenomics 16s RNA
Measured: 3 MONTHS, 6 MONTHS
Personality traits assessed by the Minnesota Multiphasic Personality Inventory questionnaire (MMPI)
Measured: MONTH 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start31 May 2022
- Primary completionJul 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire DAIEN, MD, Study director, UH of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198271
- Sponsor's protocol ID
- RECHMPL21_0533
- Acronym
- DISRUPT-estRA
- Status last verified
- Sep 2023
- First submitted
- 5 Jan 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Controlling Environmental Risk Factors in Established RA
- ClinicalTrials.gov ID
- NCT05198271
- Acronym / sponsor ID
- DISRUPT-estRA / RECHMPL21_0533
- Conditions
- Rheumatoid Arthritis
- Keywords
- prevention, smoking, diet, periodontitis, physical activity, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- The secondary endpoints will be:
- 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.
- For each risk factors: number of patients who corrected it at 3 and 6 months.
- RA activity measured by DAS28-CRP + RAID questionnaire, biological markers
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Management of risk factors | Experimental | Other: Management of risk factors, Behavioral: Smoking cessation, Behavioral: weightloss, Other: periodontal disease treatment, Behavioral: increased physical activity, Behavioral: Decreased anxiety-6 month program for reduction /correction of risk factors in patient with active RA : 1. Smoking cessation 2. weightloss 3. Increased physical activity 4. Periodontal treatment 5. Decreased anxiety |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- BMI ≥25 kg / m²
- Low physical activity (IPAQ short version)
- Active smoking
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Management of risk factors |
| 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" | Behavioural | Management of risk factors |
| 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 | Behavioural | Management of risk factors |
| 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 | Other | Management of risk factors |
| increased physical activity- For patients with low physical activity: Follow-up by level gp session: 45 '/ week for 3 months | Behavioural | Management of risk factors |
| 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 | Behavioural | Management of risk factors |
Primary outcome
Estimate the effectiveness at 6 months of this program on the overall reduction / correction of risk factors.
Time frame: 6 MONTHS
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
5 secondary outcomes
To assess the acceptability and adherence of RA patients to the intervention program.
Time frame: 6 MONTHS
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.
Time frame: 3 MONTHS
RA activity
Time frame: 3 MONTHS, 6 MONTHS
Distribution of the different germs of the oral and fecal micobiota and alpha and beta diversity
Time frame: 3 MONTHS, 6 MONTHS
Personality traits assessed by the Minnesota Multiphasic Personality Inventory questionnaire (MMPI)
Time frame: MONTH 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire DAIEN, MD study director
UH of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management of risk factors, Smoking cessation and weightloss in people with Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire DAIEN, MD (+33467337794, c-daien@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate the effectiveness at 6 months of this program on the overall reduction / correction of risk factors. (time frame: 6 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.