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Changes in Body Composition Under Ustekinumab in PsA

NCT03823924 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2022-10-17

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Julien Paccou, MD,PhD · University Hospital, Lille

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2021-07-11
Completion
2021-07-11

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823924 on ClinicalTrials.gov