Clinical trial NCT03823924: Changes in Body Composition Under Ustekinumab in PsA
Official title: Body Composition and Bone Mineral Density in Patients With Psoriatic Arthritis and Changes After 6 Months of Treatment With Ustekinumab
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis
ustekinumab
body composition
bone mineral density
adiposity
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceuticals
First posted: 2019-01-31
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with psoriatic arthritis and controls

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 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


Eligibility criteria: Inclusion Criteria:

* Psoriatic arthritis:

  1. Men and women ≥ 18 years
  2. Patients with PsA according to CASPAR criteria,
  3. Patients who do not have yet started ustekinumab,
  4. Patients who signed the informed consent.
* Healthy volunteers:

  1. Men and women ≥ 18 years
  2. Patients who signed the informed consent.

     Exclusion Criteria:
* Items 1 to 10 are applicable to healthy volunteers and PsA

  1. History of fragility fracture AND / OR T-score ≤-3 if ≥50 years AND / OR Z-score ≤-3 if \<50 years during the screening phase,
  2. Corticosteroids ≥10 mg / day,
  3. Diseases or treatments affecting bone metabolism (breast cancer with anti-aromatase, malabsorption, primary hyperparathyroidism, uncontrolled hyperthyroidism ...),
  4. History of radiotherapy on the lumbar spine or hip,
  5. Patients undergoing hormone replacement therapy (HRT) or patients already on anti-osteoporotic therapy (bisphosphonates, strontium ranelate, teriparatide or denosumab),
  6. Chronic kidney disease with creatinine clearance (CKD-EPI) ≤ 30 ml / min,
  7. Weight\> 160 kg,
  8. Patients under restrictive diet or considering a diet of this type during the study period,
  9. Patients who have an intense exercise program or plan to benefit from it during the study period,
  10. Pregnant or lactating women or having a pregnancy project,

Primary outcomes:
measure: Visceral adiposity (VAT)
timeFrame: At baseline
Secondary outcomes:
measure: Total lean mass
timeFrame: At baseline
measure: Total fat mass
timeFrame: At baseline
measure: Bone mineral density
timeFrame: At baseline
measure: Change in total fat mass (TBF, %) under ustekinumab in PsA
timeFrame: at baseline and at 6 months (± 2 months)
measure: Change in total lean mass (TLM, kg) under ustekinumab in PsA
timeFrame: at baseline and at 6 months (± 2 months)
measure: Change in visceral adiposity (cm²) under ustekinumab in PsA
timeFrame: at baseline and at 6 months (± 2 months)
measure: Change in bone mineral density (BMD, g/cm²) under ustekinumab in PsA
timeFrame: at baseline and at 6 months (± 2 months)
measure: Change in makers of bone remodeling under ustekinumab in PsA
timeFrame: at baseline and at 6 months (± 2 months)
measure: Change in leptin under ustekinumab in PsA
timeFrame: at baseline and at 6 months (± 2 months)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Julien Paccou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: