Status:
TERMINATED
Changes in Body Composition Under Ustekinumab in PsA
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Janssen Pharmaceuticals
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
There is not much body composition and bone mineral density data available for patients with psoriatic arthritis (rheumatoid arthritis) compared to control subjects. The evaluation of the total fat m...
Eligibility Criteria
Inclusion
- Psoriatic arthritis:
- Men and women ≥ 18 years
- Patients with PsA according to CASPAR criteria,
- Patients who do not have yet started ustekinumab,
- Patients who signed the informed consent.
- Healthy volunteers:
- Men and women ≥ 18 years
- Patients who signed the informed consent.
Exclusion
- Items 1 to 10 are applicable to healthy volunteers and PsA
- History of fragility fracture AND / OR T-score ≤-3 if ≥50 years AND / OR Z-score ≤-3 if \<50 years during the screening phase,
- Corticosteroids ≥10 mg / day,
- Diseases or treatments affecting bone metabolism (breast cancer with anti-aromatase, malabsorption, primary hyperparathyroidism, uncontrolled hyperthyroidism ...),
- History of radiotherapy on the lumbar spine or hip,
- Patients undergoing hormone replacement therapy (HRT) or patients already on anti-osteoporotic therapy (bisphosphonates, strontium ranelate, teriparatide or denosumab),
- Chronic kidney disease with creatinine clearance (CKD-EPI) ≤ 30 ml / min,
- Weight\> 160 kg,
- Patients under restrictive diet or considering a diet of this type during the study period,
- Patients who have an intense exercise program or plan to benefit from it during the study period,
- Pregnant or lactating women or having a pregnancy project,
Key Trial Info
Start Date :
March 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 11 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03823924
Start Date
March 11 2019
End Date
July 11 2021
Last Update
October 17 2022
Active Locations (1)
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1
Hôpital Roger Salengro, CHU
Lille, France