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
| Type | Name | Description |
|---|---|---|
| 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). |
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.