Clinical Trials Directory

Trials / Terminated

TerminatedNCT03823924

Changes in Body Composition Under Ustekinumab in PsA

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

Status
Terminated
Phase
Study type
Observational
Enrollment
3 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDUREBone 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).

Timeline

Start date
2019-03-11
Primary completion
2021-07-11
Completion
2021-07-11
First posted
2019-01-31
Last updated
2022-10-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03823924. Inclusion in this directory is not an endorsement.