Changes in Body Composition Under Ustekinumab in PsA

Psoriatic Arthritis Clinical Trial

— STELARA-CC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03823924
• Other study ID #: 2017_39
• Secondary ID: 2018-A01552-53
• Status: Terminated
• Start date: March 11, 2019
• Est. completion date: July 11, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 11, 2021
• Est. primary completion date: July 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

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).

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Janssen Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in total fat mass (TBF, %) under ustekinumab in PsA		at baseline and at 6 months (± 2 months)
Secondary	Change in total lean mass (TLM, kg) under ustekinumab in PsA		at baseline and at 6 months (± 2 months)
Secondary	Change in visceral adiposity (cm²) under ustekinumab in PsA		at baseline and at 6 months (± 2 months)
Secondary	Change in bone mineral density (BMD, g/cm²) under ustekinumab in PsA		at baseline and at 6 months (± 2 months)
Secondary	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)
Secondary	Change in leptin under ustekinumab in PsA		at baseline and at 6 months (± 2 months)