Active Rheumatoid ArthritisNCT03346590
Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects
A study testing Energy metabolism of patients suffering from RA in people with Active Rheumatoid Arthritis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Chronic inflammation in rheumatoid arthritis is associated with adiposity, sarcopenia, cachexia, reduced activity due to functional impairment, and anti-inflammatory drugs. Patients frequently gain weight when taking anti-tumor necrosis factor (TNF) medication, prompting questions about the underlying mechanism and… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Active Rheumatoid Arthritis
- What is being tested?
- Energy metabolism of patients suffering from RA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2017to 31 Dec 2019
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- RA patients Women over 18 years old with proven active (DAS28 >3.2) RA, diagnosed based on ACR/EULAR 2010 criteria, receiving biological anti-TNF treatment for the first time.
- Covered by social security. Capable of giving informed consent and acceding to the requirements of the study.
- For high-resolution echocardiography: no hypertension, diabetes or history of cardiovascular disorders.
- Healthy volunteers (control group) The healthy female controls will be enrolled from the Centre de Recherche en Nutrition Humaine (CRNH) list of volunteers and matched to the RA patients according to age ±5 years and BMI class (<25; 25-30; >30).
Who cannot join
- Refusal to sign consent form.
- Patients under guardianship or curatorship.
- Previous exposure to biological treatment in the course of their disease.
- Suffering from a condition potentially influencing energy metabolism: infection, cancer, diabetes, thyroid dysfunction, psychiatric disorder, current smoker, pregnancy.
- High physical activity level, based on short-form IPAQ questionnaire.
- Variations in weight exceeding 5% of body weight in the previous 6 months.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Anne TOURNADRE
About this study
Chronic inflammation in rheumatoid arthritis is associated with adiposity, sarcopenia, cachexia, reduced activity due to functional impairment, and anti-inflammatory drugs. Patients frequently gain weight when taking anti-tumor necrosis factor (TNF) medication, prompting questions about the underlying mechanism and long-term cardiovascular and metabolic tolerance associated with these drugs The primary objective of this study is to analyze the impact of anti-TNF treatment during the first year of administration on the energy metabolism of patients suffering from RA, assessed as an absolute value (before-after) and in comparison with a standard measured in healthy matched subjects.
Read the detailed description
Few studies have been focused on the combined evolution of body composition, energy expenditure, physical activity, muscle performance, and nutritional intake in patients taking anti-TNFs.
This study's objective is to assess the impact of anti-TNF treatment during the first year of administration on the energy metabolism of RA patients, measuring variations in basal daily energy expenditure and per type of expenditure using indirect calorimetry with calorimetric chambers. Investigator also aim to define standardized values for RA patients compared to healthy matched controls and to be able to monitor the evolution of these different values during treatment compared to this standard.
This will be an exploratory study with a longitudinal follow-up of the cohort in patients treated in a market authorization context and involving a case/control study. Investigator judged the inclusion of healthy controls justified by the current lack of data comparing the different components of energy metabolism in active RA patients versus healthy subjects using calorimetric chamber measurement. The aim is to obtain reference values to situate RA-specific values in comparison before and after treatment. Investigator considered selecting controls from the RA patients unjustified given how essential it is to commence treatment in active RA cases (1 year with placebo not justifiable). A previously-treated inactive RA population with no inflammation would not be comparable to patients with active RA, and neither would a population with active RA treated with conventional treatment or a different biotherapy to anti-TNFs. Investigator also chose to perform a second assessment at 6 months without calorimetric chamber measurement but rather an indirect measurement using actimetry in order to limit costs and patients lost-to-follow-up due to treatment modification (failure or intolerance), all the while maintaining full assessment at 12 months. Scheduling the assessment at 12 months is justified by published studies' reports of delay before significant weight gain manifests, and enables us to maintain homogeneity as regards variations in physical activity and nutritional intake linked to seasonal changes.
- Conditions
- Active Rheumatoid Arthritis
- Being tested
- Energy metabolism of patients suffering from RA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy metabolism of patients suffering from RABehavioural
Energy metabolism of patients suffering from RA
| Study group | Role | What they receive |
|---|---|---|
| 16 patients with active RA | Active comparator | Women over 18 years old with proven active (DAS28 >3.2) RA, diagnosed based on ACR/EULAR 2010 criteria, receiving biological anti-TNF treatment for the first time.
Covered by social security. Capable of giving informed consent and acceding to the requirements of the study. For high-resolution echocardiography: no hypertension, diabetes or history of cardiovascular disorders. Receives: Behavioral: Energy metabolism of patients suffering from RA |
| 8 Healthy volunteers (control group) | Sham comparator | Healthy volunteers (control group) The healthy female controls will be enrolled from the Centre de Recherche en Nutrition Humaine (CRNH) list of volunteers and matched to the RA patients according to age ±5 years and BMI class (<25; 25-30; >30). Receives: Behavioral: Energy metabolism of patients suffering from RA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous measurement of energy expenditure and cardiac rhythm in calorimetric chamber
Continuous measurement of energy expenditure and cardiac rhythm in calorimetric chamber for 36 hours: at rest, waking, during two physical activity sessions (treadmill walking at 4km/h for 30min), sleeping.
Measured: for 36 hours
Indirect assessment of energy expenditure
Indirect assessment of energy expenditure by measuring physical activity using home actimetry(Armband) under normal living conditions for 4 days and in the calorimetric chamber for calibration.
Measured: for 4 days
Nutritionist assessment of nutritional intake
Nutritionist assessment of nutritional intake during the 2 days preceding energy expenditure measurement.
Measured: during the 2 days preceding energy expenditure measurement.
Previously-scheduled tests for the RCVRIC protocol
Measured: at day 1
Secondary outcomes (3)
Indirect assessment of energy expenditure via measurement of physical activity using calibrated actimetry (Armband)
Indirect assessment of energy expenditure via measurement of physical activity using calibrated actimetry (Armband) at home in normal living conditions over 4 days.
Measured: at 6 months
Nutritionist evaluation of nutritional intake over 2 days
Measured: at 6 months
Previously-scheduled tests for the RCVRIC study protocol (M6):
DXA, pQCT, physical strength and performance, physical activity and nutrition questionnaires, cardiovascular risk, serum and urine bank research.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start30 Nov 2017 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Responsible party
- Sponsor
- Investigators
- Anne TOURNADRE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346590
- Sponsor's protocol ID
- CHU-365
- Other IDs
- 2017-A01654-49
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects
- ClinicalTrials.gov ID
- NCT03346590
- Acronym / sponsor ID
- CHU-365
- Conditions
- Active Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Centre de Recherche en Nutrition Humaine d'Auvergne
- Study start
- 30 Nov 2017 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 17 Nov 2017 (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.
Chronic inflammation in rheumatoid arthritis is associated with adiposity, sarcopenia, cachexia, reduced activity due to functional impairment, and anti-inflammatory drugs. Patients frequently gain weight when taking anti-tumor necrosis factor (TNF) medication, prompting questions about the underlying mechanism and long-term cardiovascular and metabolic tolerance associated with these drugs The primary objective of this study is to analyze the impact of anti-TNF treatment during the first year of administration on the energy metabolism of patients suffering from RA, assessed as an absolute value (before-after) and in comparison with a standard measured in healthy matched subjects.
Detailed description
Few studies have been focused on the combined evolution of body composition, energy expenditure, physical activity, muscle performance, and nutritional intake in patients taking anti-TNFs.
This study's objective is to assess the impact of anti-TNF treatment during the first year of administration on the energy metabolism of RA patients, measuring variations in basal daily energy expenditure and per type of expenditure using indirect calorimetry with calorimetric chambers. Investigator also aim to define standardized values for RA patients compared to healthy matched controls and to be able to monitor the evolution of these different values during treatment compared to this standard.
This will be an exploratory study with a longitudinal follow-up of the cohort in patients treated in a market authorization context and involving a case/control study. Investigator judged the inclusion of healthy controls justified by the current lack of data comparing the different components of energy metabolism in active RA patients versus healthy subjects using calorimetric chamber measurement. The aim is to obtain reference values to situate RA-specific values in comparison before and after treatment. Investigator considered selecting controls from the RA patients unjustified given how essential it is to commence treatment in active RA cases (1 year with placebo not justifiable). A previously-treated inactive RA population with no inflammation would not be comparable to patients with active RA, and neither would a population with active RA treated with conventional treatment or a different biotherapy to anti-TNFs. Investigator also chose to perform a second assessment at 6 months without calorimetric chamber measurement but rather an indirect measurement using actimetry in order to limit costs and patients lost-to-follow-up due to treatment modification (failure or intolerance), all the while maintaining full assessment at 12 months. Scheduling the assessment at 12 months is justified by published studies' reports of delay before significant weight gain manifests, and enables us to maintain homogeneity as regards variations in physical activity and nutritional intake linked to seasonal changes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 16 patients with active RA | Active comparator | Behavioral: Energy metabolism of patients suffering from RAWomen over 18 years old with proven active (DAS28 >3.2) RA, diagnosed based on ACR/EULAR 2010 criteria, receiving biological anti-TNF treatment for the first time. Covered by social security. Capable of giving informed consent and acceding to the requirements of the study. For high-resolution echocardiography: no hypertension, diabetes or history of cardiovascular disorders. |
| 8 Healthy volunteers (control group) | Sham comparator | Behavioral: Energy metabolism of patients suffering from RAHealthy volunteers (control group) The healthy female controls will be enrolled from the Centre de Recherche en Nutrition Humaine (CRNH) list of volunteers and matched to the RA patients according to age ±5 years and BMI class (<25; 25-30; >30). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- RA patients Women over 18 years old with proven active (DAS28 >3.2) RA, diagnosed based on ACR/EULAR 2010 criteria, receiving biological anti-TNF treatment for the first time.
- Covered by social security. Capable of giving informed consent and acceding to the requirements of the study.
- For high-resolution echocardiography: no hypertension, diabetes or history of cardiovascular disorders.
- Healthy volunteers (control group) The healthy female controls will be enrolled from the Centre de Recherche en Nutrition Humaine (CRNH) list of volunteers and matched to the RA patients according to age ±5 years and BMI class (<25; 25-30; >30).
Key exclusion criteria (6 listed)
- Refusal to sign consent form.
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 |
|---|---|---|
| Energy metabolism of patients suffering from RAEnergy metabolism of patients suffering from RA | Behavioural | 16 patients with active RA, 8 Healthy volunteers (control group) |
Primary outcome
Continuous measurement of energy expenditure and cardiac rhythm in calorimetric chamber
Time frame: for 36 hours
Continuous measurement of energy expenditure and cardiac rhythm in calorimetric chamber for 36 hours: at rest, waking, during two physical activity sessions (treadmill walking at 4km/h for 30min), sleeping.
Indirect assessment of energy expenditure
Time frame: for 4 days
Indirect assessment of energy expenditure by measuring physical activity using home actimetry(Armband) under normal living conditions for 4 days and in the calorimetric chamber for calibration.
Nutritionist assessment of nutritional intake
Time frame: during the 2 days preceding energy expenditure measurement.
Nutritionist assessment of nutritional intake during the 2 days preceding energy expenditure measurement.
Previously-scheduled tests for the RCVRIC protocol
Time frame: at day 1
3 secondary outcomes
Indirect assessment of energy expenditure via measurement of physical activity using calibrated actimetry (Armband)
Time frame: at 6 months
Nutritionist evaluation of nutritional intake over 2 days
Time frame: at 6 months
Previously-scheduled tests for the RCVRIC study protocol (M6):
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
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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.
Anne TOURNADRE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy metabolism of patients suffering from RA in people with Active Rheumatoid Arthritis, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 6 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 21 Nov 2017. 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. Some participants in this study may receive a placebo. 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 Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous measurement of energy expenditure and cardiac rhythm in calorimetric chamber (time frame: for 36 hours). The study lists 4 primary outcomes in all. 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 21 Nov 2017.