Rheumatoid ArthritisRAFATNCT05269069
Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study
An observational study of Rheumatoid Arthritis, run by University Hospital, Lille at 1 site in France.
Trial summary
During rheumatoid arthritis (RA) (in comparison with control subjects), body composition is altered with a loss of lean body mass, bone mass and an accumulation of fat mass. Determination of total body fat and particularly its abdominal distribution (visceral adiposity) is important because of the cardiovascular… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Assessment of body composition, bone mineral density and bone marrow adiposity.
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 17 Aug 2022to 2 Apr 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with rheumatoid arthritis and controls
Who may be able to join
- Subjects:
- Males and females of age (age ≥ 18 years). Patients with RA according to American College of Rheumatology/EULAR 2010 criteria, Patients who have signed the informed consent
- Controls:
- Males and females of age (age ≥ 18 years). subjects who have signed the informed consent
Who cannot join
- Patients who have received more than three anti-TNFinhibitors
- Patients who have previously received a Janus kinase (JAK) inhibitor
- Patients with concomitant therapies as described below :
- A combination with methotrexate is allowed if methotrexate is started ≥3 months before the start of the study and at a stable dosage (≤25 mg/week) for ≥4 weeks.
- A combination to conventional synthetic DMARDs (csDMARDs) other than methotrexate is not allowed within 4 weeks before and/or during the clinical trial
- Corticosteroid therapy >10mg/d prednisolone equivalent is not allowed
Show all 14Show fewer
- Intra-articular injections of corticosteroids are allowed if their number is less than or equal to 4
- Intravenous corticosteroid infusions are not allowed
- Immunosuppressants other than methotrexate are not allowed
- History or discovery of an osteoporotic fracture AND/OR T-score ≤-3 if ≥50 years old AND/OR Z-score ≤-3 if <50 years old during the screening phase,
- Corticosteroid therapy ≥ 10mg/d prednisolone equivalent,
- Pathologies or treatments affecting bone metabolism (breast cancer with antiaromatase, digestive malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism...),
- History of radiotherapy on the lumbar spine or the hip studied,
- Patients undergoing hormone replacement therapy (HRT) or patients already under anti-osteoporotic treatment (bisphosphonates, strontium ranelate, teriparatide or denosumab) apart from calcium and/or vitamin D supplementation, Chronic renal failure with creatinine clearance (CKD-EPI formula) ≤ 30 ml/min,
Trial locations and contacts
1 site in 1 country.
About this study
During rheumatoid arthritis (RA) (in comparison with control subjects), body composition is altered with a loss of lean body mass, bone mass and an accumulation of fat mass.
Determination of total body fat and particularly its abdominal distribution (visceral adiposity) is important because of the cardiovascular (excess cardiovascular risk), metabolic (insulin resistance, diabetes and dyslipidemia) and bone (increased fracture risk) risks associated with this endocrine organ. Moreover, we do not have data concerning medullary adiposity in RA.
This pilot case-control study will be compare body composition, bone marrow adiposity and bone mineral density in patients with RA versus healthy volunteers.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Assessment of body composition, bone mineral density and bone marrow adiposity.
- Keywords
- Body composition, rheumatoid arthritis, visceral adiposity, marrow adiposity, bone mineral density
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of body composition, bone mineral density and bone marrow adiposity.Other
DXA for body composition and bone mineral density, MRI for bone marrow adiposity and blood tests (leptine, CTX, P1NP)
| Study group | Role | What they receive |
|---|---|---|
| Patients with rheumatoid arthritis | patients with rheumatoid arthritis Receives: Other: Assessment of body composition, bone mineral density and bone marrow adiposity. | |
| Control group | healthy volunteers without rheumatoid arthritis matched for age, sex, BMI and menopausal status Receives: Other: Assessment of body composition, bone mineral density and bone marrow adiposity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of visceral adiposity (VAT) in cm² at inclusion.
A whole body composition acquisition by dual energy x-ray absorptiometry (DXA) will calculate visceral adiposity
Measured: Baseline
Secondary outcomes (7)
Measures of lean body mass (LBM) in kg
Measured: Baseline
Measures of total body fat (TBF) in %
Measured: Baseline
Bone mineral density (BMD) measurements (in mg/cm²) at the lumbar spine (L1-L4) and total non-dominant hip
Measured: Baseline
Measurements of bone remodeling markers (CTX and P1NP)
Measured: Baseline
Level of Leptin
Measured: Baseline
Measurement of bone marrow adiposity (in %) at the lumbar spine
Measured: Baseline
Short Physical Performance Battery (SPPB)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start17 Aug 2022
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Why it stopped: The sponsor decided to stop financing the study.
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, LilleThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Jean-Guillaume LETARTOUILLY, MD, MSc, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269069
- Sponsor's protocol ID
- 2021_0845
- Other IDs
- 2021-A03187-34
- Acronym
- RAFAT
- Status last verified
- May 2024
- First submitted
- 7 Feb 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study
- ClinicalTrials.gov ID
- NCT05269069
- Acronym / sponsor ID
- RAFAT / 2021_0845
- Conditions
- Rheumatoid Arthritis
- Keywords
- Body composition, rheumatoid arthritis, visceral adiposity, marrow adiposity, bone mineral density
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The sponsor decided to stop financing the study.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 7 Mar 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.
During rheumatoid arthritis (RA) (in comparison with control subjects), body composition is altered with a loss of lean body mass, bone mass and an accumulation of fat mass.
Determination of total body fat and particularly its abdominal distribution (visceral adiposity) is important because of the cardiovascular (excess cardiovascular risk), metabolic (insulin resistance, diabetes and dyslipidemia) and bone (increased fracture risk) risks associated with this endocrine organ. Moreover, we do not have data concerning medullary adiposity in RA.
This pilot case-control study will be compare body composition, bone marrow adiposity and bone mineral density in patients with RA versus healthy volunteers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatoid arthritis | – | Other: Assessment of body composition, bone mineral density and bone marrow adiposity.patients with rheumatoid arthritis |
| Control group | – | Other: Assessment of body composition, bone mineral density and bone marrow adiposity.healthy volunteers without rheumatoid arthritis matched for age, sex, BMI and menopausal status |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis and controls
Key inclusion criteria (4 listed)
- Males and females of age (age ≥ 18 years). Patients with RA according to American College of Rheumatology/EULAR 2010 criteria, Patients who have signed the informed consent
- Males and females of age (age ≥ 18 years). subjects who have signed the informed consent
Key exclusion criteria (14 listed)
- Patients who have received more than three anti-TNFinhibitors
- Patients who have previously received a Janus kinase (JAK) inhibitor
- Patients with concomitant therapies as described below :
- A combination with methotrexate is allowed if methotrexate is started ≥3 months before the start of the study and at a stable dosage (≤25 mg/week) for ≥4 weeks.
- A combination to conventional synthetic DMARDs (csDMARDs) other than methotrexate is not allowed within 4 weeks before and/or during the clinical trial
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 |
|---|---|---|
| Assessment of body composition, bone mineral density and bone marrow adiposity.DXA for body composition and bone mineral density, MRI for bone marrow adiposity and blood tests (leptine, CTX, P1NP) | Other | Control group, Patients with rheumatoid arthritis |
Primary outcome
Measurement of visceral adiposity (VAT) in cm² at inclusion.
Time frame: Baseline
A whole body composition acquisition by dual energy x-ray absorptiometry (DXA) will calculate visceral adiposity
7 secondary outcomes
Measures of lean body mass (LBM) in kg
Time frame: Baseline
Measures of total body fat (TBF) in %
Time frame: Baseline
Bone mineral density (BMD) measurements (in mg/cm²) at the lumbar spine (L1-L4) and total non-dominant hip
Time frame: Baseline
Measurements of bone remodeling markers (CTX and P1NP)
Time frame: Baseline
Level of Leptin
Time frame: Baseline
Measurement of bone marrow adiposity (in %) at the lumbar spine
Time frame: Baseline
Short Physical Performance Battery (SPPB)
Time frame: Baseline
Results and safety
The study was stopped early (reason given: The sponsor decided to stop financing the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
Jean-Guillaume LETARTOUILLY, MD, MSc principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by University Hospital, Lille 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 14 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: stopped early, as of the sponsor's last update on 16 May 2024. 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?
The study was stopped early (reason given: The sponsor decided to stop financing the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of visceral adiposity (VAT) in cm² at inclusion. (time frame: Baseline). 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 16 May 2024.