Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Changes in Body Composition Under Ustekinumab in PsA (STELARA-CC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823924
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : August 26, 2020
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
University Hospital, Lille

Brief 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


Condition or disease Intervention/treatment
Psoriatic Arthritis Procedure: Bone mineral density (BMD)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Body Composition and Bone Mineral Density in Patients With Psoriatic Arthritis and Changes After 6 Months of Treatment With Ustekinumab
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022


Group/Cohort Intervention/treatment
Psoriatic arthritis 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).


Healthy volunteers 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).





Primary Outcome Measures :
  1. Visceral adiposity (VAT) [ Time Frame: At baseline ]
    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).


Secondary Outcome Measures :
  1. Total lean mass [ Time Frame: At baseline ]
    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).

  2. Total fat mass [ Time Frame: At baseline ]
    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).

  3. Bone mineral density [ Time Frame: At baseline ]
    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).

  4. Change in total fat mass (TBF, %) under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]
  5. Change in total lean mass (TLM, kg) under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]
  6. Change in visceral adiposity (cm²) under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]
  7. Change in bone mineral density (BMD, g/cm²) under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]
  8. Change in makers of bone remodeling under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]
    C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP)

  9. Change in leptin under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with psoriatic arthritis and controls
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823924


Contacts
Layout table for location contacts
Contact: Julien Paccou, MD,PhD 03 20 44 69 26 ext +33 julien.paccou@chru-lille.fr

Locations
Layout table for location information
France
Hôpital Roger Salengro, CHU Recruiting
Lille, France
Principal Investigator: Julien Paccou, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Janssen Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Julien Paccou, MD,PhD University Hospital, Lille
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03823924    
Other Study ID Numbers: 2017_39
2018-A01552-53 ( Other Identifier: ID-RCB number, ANSM )
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Psoriatic arthritis
ustekinumab
body composition
bone mineral density
adiposity
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases