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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A03187-34 | Other Identifier | ID-RCB number, ANSM |
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The sponsor decided to stop financing the study.
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with rheumatoid arthritis | patients with rheumatoid arthritis |
| |
| Control group | healthy volunteers without rheumatoid arthritis matched for age, sex, BMI and menopausal status |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of lean body mass (LBM) in kg | Baseline | |
| Measures of total body fat (TBF) in % | Baseline | |
| Bone mineral density (BMD) measurements (in mg/cm²) at the lumbar spine (L1-L4) and total non-dominant hip |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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Patients with rheumatoid arthritis and controls
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Guillaume LETARTOUILLY, MD, MSc | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Salengro - Chu Lille | Lille | France |
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| Baseline |
| Measurements of bone remodeling markers (CTX and P1NP) | Baseline |
| Level of Leptin | Baseline |
| Measurement of bone marrow adiposity (in %) at the lumbar spine | Baseline |
| Short Physical Performance Battery (SPPB) | Baseline |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015519 | Bone Density |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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