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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05269069
Other study ID # 2021_0845
Secondary ID 2021-A03187-34
Status Terminated
Phase
First received
Last updated
Start date August 17, 2022
Est. completion date April 2, 2024

Study information

Verified date May 2024
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 (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.


Recruitment information / eligibility

Status Terminated
Enrollment 52
Est. completion date April 2, 2024
Est. primary completion date April 2, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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: - 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 - 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,

Study Design


Intervention

Other:
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)

Locations

Country Name City State
France Hop Salengro - Chu Lille Lille

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Measures of lean body mass (LBM) in kg Baseline
Secondary Measures of total body fat (TBF) in % Baseline
Secondary Bone mineral density (BMD) measurements (in mg/cm²) at the lumbar spine (L1-L4) and total non-dominant hip Baseline
Secondary Measurements of bone remodeling markers (CTX and P1NP) Baseline
Secondary Level of Leptin Baseline
Secondary Measurement of bone marrow adiposity (in %) at the lumbar spine Baseline
Secondary Short Physical Performance Battery (SPPB) Baseline
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