Changes in Body Composition Under Ustekinumab in PsA (NCT03823924) | Clinical Trial Compass
TerminatedNot Applicable
Changes in Body Composition Under Ustekinumab in PsA
Stopped: logistic problems
France3 participantsStarted 2019-03-11
Plain-language 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 mass and in particular of its abdominal distribution (visceral adiposity) is important because an excessive adiposity generates adverse effects on the health (hypertension, dyslipidemia, cardiovascular risk and resistance to the insulin).
In addition, data on changes in body composition and bone mineral density were not available under a new psA treatment, namely ustekinumab (anti-IL12 / 23 antibody).
It is proposed to conduct a pilot study to evaluate body composition, distribution (visceral adiposity) and bone mineral density in patients with psoriatic arthritis (versus control subjects) and their changes after 6 months of treatment with ustekinumab
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Men and women ≥ 18 years
✓. Patients who signed the informed consent.
Exclusion criteria
✕. 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,