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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03823924
Other study ID # 2017_39
Secondary ID 2018-A01552-53
Status Terminated
Phase
First received
Last updated
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
Health authority
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,

Study Design


Related Conditions & MeSH terms


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)
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