Changes in Body Composition Under Ustekinumab in PsA

  • STATUS
    Recruiting
  • End date
    Jul 25, 2022
  • participants needed
    60
  • sponsor
    University Hospital, Lille
Updated on 25 January 2021
ustekinumab
arthritis
rheumatoid arthritis

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

Details
Condition Psoriasis, PSORIATIC ARTHRITIS, Arthritis, Arthritis and Arthritic Pain, Psoriasis and Psoriatic Disorders, Arthritis and Arthritic Pain (Pediatric)
Treatment Bone mineral density (BMD)
Clinical Study IdentifierNCT03823924
SponsorUniversity Hospital, Lille
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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