Status:
TERMINATED
Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief 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 bo...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
August 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05269069
Start Date
August 17 2022
End Date
April 2 2024
Last Update
May 16 2024
Active Locations (1)
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1
Hop Salengro - Chu Lille
Lille, France