STELARA-CC: Changes in Body Composition Under Ustekinumab in PsA

Sponsor

University Hospital, Lille (Other)

Overall Status

Unknown status

CT.gov ID

NCT03823924

Collaborator

Janssen Pharmaceuticals (Industry)

Enrollment

Location

39.7

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Procedure: Bone mineral density (BMD)

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 11, 2019

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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).
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).

Arm

Intervention/Treatment

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).

Healthy volunteers

Procedure: Bone mineral density (BMD)

Outcome Measures

Primary Outcome Measures

Visceral adiposity (VAT) [At baseline]
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).

Secondary Outcome Measures

Total lean mass [At baseline]
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).
Total fat mass [At baseline]
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).
Bone mineral density [At baseline]
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).
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 [at baseline and at 6 months (± 2 months)]
C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP)
Change in leptin under ustekinumab in PsA [at baseline and at 6 months (± 2 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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,