Changes in Body Composition Under Ustekinumab in PsA

NCT03823924 | Terminated

• 2 other identifiers: 2017_392018-A01552-53
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritis; ustekinumab; body composition; bone mineral density; adiposity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Total lean mass

  At baseline

• Total fat mass

  At baseline

• Bone mineral density

  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)

Study Arms (2)

Psoriatic arthritis

Procedure: Bone mineral density (BMD)

Healthy volunteers

Procedure: Bone mineral density (BMD)

Interventions

Bone mineral density (BMD) PROCEDURE

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).

Healthy volunteers; Psoriatic arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with psoriatic arthritis and controls

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Lille: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Obesity

Interventions

Bone Density

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Julien Paccou, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 31, 2019
• Study Start: March 11, 2019
• Primary Completion: July 11, 2021
• Study Completion: July 11, 2021
• Last Updated: October 17, 2022

Record last verified: 2021-09

Locations

FR (1)