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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01552-53 | Other Identifier | ID-RCB number, ANSM |
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logistic problems
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| Name | Class |
|---|---|
| Janssen Pharmaceuticals | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriatic arthritis |
| ||
| Healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone mineral density (BMD) | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Visceral adiposity (VAT) | 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). | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Total lean mass | 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). | At baseline |
| Total fat mass |
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Inclusion Criteria:
Psoriatic arthritis:
Healthy volunteers:
Men and women ≥ 18 years
Patients who signed the informed consent.
Exclusion Criteria:
Items 1 to 10 are applicable to healthy volunteers and PsA
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Patients with psoriatic arthritis and controls
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| Name | Affiliation | Role |
|---|---|---|
| Julien Paccou, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro, CHU | Lille | France |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D015519 | Bone Density |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
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). |
| At baseline |
| Bone mineral density | 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). | At baseline |
| Change in total fat mass (TBF, %) under ustekinumab in PsA | at baseline and at 6 months (± 2 months) |
| Change in total lean mass (TLM, kg) under ustekinumab in PsA | at baseline and at 6 months (± 2 months) |
| Change in visceral adiposity (cm²) under ustekinumab in PsA | at baseline and at 6 months (± 2 months) |
| Change in bone mineral density (BMD, g/cm²) under ustekinumab in PsA | at baseline and at 6 months (± 2 months) |
| Change in makers of bone remodeling under ustekinumab in PsA | C-telopeptide (Ctx), Procollagen type 1 amino-terminal propeptide (P1NP) | at baseline and at 6 months (± 2 months) |
| Change in leptin under ustekinumab in PsA | at baseline and at 6 months (± 2 months) |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |