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

Body Composition and Bone Mineral Density in Patients With Psoriatic Arthritis and Changes After 6 Months of Treatment With Ustekinumab

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

Study Overview

• Status: Terminated
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Procedure: Bone mineral density (BMD)

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Roger Salengro, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with psoriatic arthritis and controls

Description

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,

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers	Procedure: Bone mineral density (BMD); The bone mineral density (BMD) performed by DXA, which will allow the analysis of bone density (mg / cm²) at the lumbar spine (BMD L1 to L4) and the total hip (non-dominant). This examination will also allow an analysis of the body composition at the same time (lean mass, fat mass and bone mass for the whole body).
Psoriatic arthritis	Procedure: Bone mineral density (BMD); The bone mineral density (BMD) performed by DXA, which will allow the analysis of bone density (mg / cm²) at the lumbar spine (BMD L1 to L4) and the total hip (non-dominant). This examination will also allow an analysis of the body composition at the same time (lean mass, fat mass and bone mass for the whole body).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visceral adiposity (VAT)	Comparison at baseline of visceral adiposity (VAT) in cm² between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total lean mass	Comparison at baseline of total lean mass (TLM, kg), between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).	At baseline
Total fat mass	Comparison at baseline of total fat mass (TBF, %) between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).	At baseline
Bone mineral density	Comparison at baseline of bone mineral density (BMD, g/cm²) between PsA (n = 30) and healthy volunteers (n = 30) matched on age (± 5 years, ≥ 18 years), sex, menopausal status for women and body mass index (BMI, ± 3 kg / m²).	At baseline
Change in total fat mass (TBF, %) under ustekinumab in PsA		at baseline and at 6 months (± 2 months)
Change in total lean mass (TLM, kg) under ustekinumab in PsA		at baseline and at 6 months (± 2 months)
Change in visceral adiposity (cm²) under ustekinumab in PsA		at baseline and at 6 months (± 2 months)
Change in bone mineral density (BMD, g/cm²) under ustekinumab in PsA		at baseline and at 6 months (± 2 months)
Change in makers of bone remodeling under ustekinumab in PsA	C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP)	at baseline and at 6 months (± 2 months)
Change in leptin under ustekinumab in PsA		at baseline and at 6 months (± 2 months)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Janssen Pharmaceuticals
• Investigators: Principal Investigator: Julien Paccou, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): July 11, 2021
• Study Completion (Actual): July 11, 2021

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 31, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: body composition; adiposity; Psoriatic arthritis; bone mineral density; ustekinumab
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: 2017_39; 2018-A01552-53 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No