Changes in Body Composition Under Ustekinumab in PsA (STELARA-CC)

University Hospital, Lille

Status: Terminated

Conditions: Psoriatic Arthritis

Treatments: Procedure: Bone mineral density (BMD)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03823924

2018-A01552-53 (Other Identifier)

2017_39

Details and patient eligibility

About

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

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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,

Trial design

3 participants in 2 patient groups

Psoriatic arthritis

Treatment:

Procedure: Bone mineral density (BMD)

Healthy volunteers

Treatment:

Procedure: Bone mineral density (BMD)