Changes in Body Composition Under Ustekinumab in PsA

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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,

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03823924
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Lille
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Julien Paccou, MD,PhD
Principal Investigator Affiliation University Hospital, Lille
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis
Arms & Interventions

Arms

: Psoriatic arthritis

: Healthy volunteers

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).

Contact a Trial Team

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International Sites

Hôpital Roger Salengro, CHU, Lille, France

Status

Recruiting

Address

Hôpital Roger Salengro, CHU

Lille, ,

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