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

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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

Tracking Information
First Submitted Date January 14, 2019
First Posted Date January 31, 2019
Last Update Posted Date August 26, 2020
Actual Study Start Date March 11, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 28, 2019)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 28, 2019)
  • 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).
  • 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).
  • 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).
  • Change in total fat mass (TBF, %) under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]
  • Change in total lean mass (TLM, kg) under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]
  • Change in visceral adiposity (cm²) under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]
  • Change in bone mineral density (BMD, g/cm²) under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]
  • 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)
  • Change in leptin under ustekinumab in PsA [ Time Frame: at baseline and at 6 months (± 2 months) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Changes in Body Composition Under Ustekinumab in PsA
Official Title Body Composition and Bone Mineral Density in Patients With Psoriatic Arthritis and Changes After 6 Months of Treatment With Ustekinumab
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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with psoriatic arthritis and controls
Condition Psoriatic Arthritis
Intervention 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).

Study Groups/Cohorts
  • Psoriatic arthritis
    Intervention: Procedure: Bone mineral density (BMD)
  • Healthy volunteers
    Intervention: Procedure: Bone mineral density (BMD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 28, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility 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,
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Julien Paccou, MD,PhD 03 20 44 69 26 ext +33 julien.paccou@chru-lille.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03823924
Other Study ID Numbers 2017_39
2018-A01552-53 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Janssen Pharmaceuticals
Investigators
Principal Investigator: Julien Paccou, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date August 2020