Psoriatic ArthritisSTELARA-CCNCT03823924
Changes in Body Composition Under Ustekinumab in PsA
An observational study of Psoriatic Arthritis, run by University Hospital, Lille at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Bone mineral density (BMD)
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2019to 11 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with psoriatic arthritis and controls
Who may be able to join
- Psoriatic arthritis:
- Men and women ≥ 18 years
- Patients with PsA according to CASPAR criteria,
- Patients who do not have yet started ustekinumab,
- Patients who signed the informed consent.
- Healthy volunteers:
- Men and women ≥ 18 years
- Patients who signed the informed consent.
Who cannot join
- Items 1 to 10 are applicable to healthy volunteers and PsA
- History of fragility fracture AND / OR T-score ≤-3 if ≥50 years AND / OR Z-score ≤-3 if <50 years during the screening phase,
- Corticosteroids ≥10 mg / day,
- Diseases or treatments affecting bone metabolism (breast cancer with anti-aromatase, malabsorption, primary hyperparathyroidism, uncontrolled hyperthyroidism ...),
- History of radiotherapy on the lumbar spine or hip,
- Patients undergoing hormone replacement therapy (HRT) or patients already on anti-osteoporotic therapy (bisphosphonates, strontium ranelate, teriparatide or denosumab),
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- Chronic kidney disease with creatinine clearance (CKD-EPI) ≤ 30 ml / min,
- Weight> 160 kg,
- Patients under restrictive diet or considering a diet of this type during the study period,
- Patients who have an intense exercise program or plan to benefit from it during the study period,
- Pregnant or lactating women or having a pregnancy project,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Composition and Bone Mineral Density in Patients With Psoriatic Arthritis and Changes After 6 Months of Treatment With Ustekinumab
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).
Read more
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
- Psoriatic Arthritis
- Being tested
- Bone mineral density (BMD)
- Keywords
- Psoriatic arthritis, ustekinumab, body composition, bone mineral density, adiposity
- Medical subject headings
- Arthritis, Psoriatic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone mineral density (BMD)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis | Not described Receives: Procedure: Bone mineral density (BMD) | |
| Healthy volunteers | Not described Receives: Procedure: Bone mineral density (BMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline
Secondary outcomes (9)
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).
Measured: At baseline
Total fat mass
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).
Measured: 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).
Measured: At baseline
Change in total fat mass (TBF, %) under ustekinumab in PsA
Measured: at baseline and at 6 months (± 2 months)
Change in total lean mass (TLM, kg) under ustekinumab in PsA
Measured: at baseline and at 6 months (± 2 months)
Change in visceral adiposity (cm²) under ustekinumab in PsA
Measured: at baseline and at 6 months (± 2 months)
Change in bone mineral density (BMD, g/cm²) under ustekinumab in PsA
Measured: 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)
Measured: at baseline and at 6 months (± 2 months)
Change in leptin under ustekinumab in PsA
Measured: at baseline and at 6 months (± 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start11 Mar 2019
- Primary completion11 Jul 2021
- Study completion11 Jul 2021
Why it stopped: logistic problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Julien Paccou, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823924
- Sponsor's protocol ID
- 2017_39
- Other IDs
- 2018-A01552-53
- Acronym
- STELARA-CC
- Status last verified
- Sep 2021
- First submitted
- 14 Jan 2019
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition and Bone Mineral Density in Patients With Psoriatic Arthritis and Changes After 6 Months of Treatment With Ustekinumab
- ClinicalTrials.gov ID
- NCT03823924
- Acronym / sponsor ID
- STELARA-CC / 2017_39
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic arthritis, ustekinumab, body composition, bone mineral density, adiposity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: logistic problems
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 11 Jul 2021 (actual)
- Study completion
- 11 Jul 2021 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis | – | Procedure: Bone mineral density (BMD) |
| Healthy volunteers | – | Procedure: Bone mineral density (BMD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with psoriatic arthritis and controls
Key inclusion criteria (8 listed)
- Psoriatic arthritis:
- Healthy volunteers:
Key exclusion criteria (11 listed)
- Items 1 to 10 are applicable to healthy volunteers and PsA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Healthy volunteers, Psoriatic arthritis |
Primary outcome
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).
9 secondary outcomes
Total lean mass
Time frame: At baseline
Total fat mass
Time frame: At baseline
Bone mineral density
Time frame: At baseline
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)
Change in leptin under ustekinumab in PsA
Time frame: at baseline and at 6 months (± 2 months)
Results and safety
The study was stopped early (reason given: logistic problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Paccou, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: logistic problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral adiposity (VAT) (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.