PsoriasisNCT01356758
Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents
An observational study of Psoriasis and Atopic Dermatitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
Psoriasis is a common inflammatory disease of the skin and joints with a prevalence of 1-3% in the caucasian population of Northern Europe and the US. Similarly to other inflammatory diseases there is now substantial and accumulating evidence that psoriasis has a systemic inflammatory component. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Atopic Dermatitis, Atherosclerosis
- What is being tested?
- biological treatment
- How many people
- 126 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Nov 2015
- 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 severe psoriasis recruited from a dermatological in- and out patient clinic. Patients with severe atopic dermatitis.
Who may be able to join
- Males and females aged 18 years or above.
- Intervention group: Severe plaque psoriasis with indication for biological therapy according to national guidelines. Psoriasis Control group: Patients with similar disease activity who for personal reasons decline systemic treatment and only receive topical therapy. Atopic dermatitis group: Patients matched regarding sex, disease duration, body surface involvement, BMI and smoking habits.
- Signed informed consent form prior to initiation of any study-mandated procedure.
Who cannot join
- Significant arterial hypertension, unless well controlled with anti-hypertensive medication for at least 1 month before inclusion.
- Lipid-lowering treatment, unless well controlled for at least 1 month before inclusion.
- Congestive heart failure (NYHA group III and IV).
- Reduced kidney function (eGFR below 60).
- Oral methotrexate, ciclosporin, acitretin and fumarate esters within 1 month before inclusion. In the intervention group, patients receiving oral anti-psoriatic treatment for at least 6 months before the study start can be included, if they are maintained on the same dose during the study period.
- UVB phototherapy and PUVA photochemotherapy within 1 month prior to study start.
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- Prior treatment with infliximab, etanercept, adalimumab or ustekinumab unless less than PASI-50% reduction have been observed during this treatment.
- Investigational biological agents within 6 months prior to inclusion.
- Any other investigational drug within 1 month or 5 half lives prior to inclusion, which ever is longer.
- Concurrent immunosuppressive or anti-inflammatory treatment for immune diseases other than psoriasis and psoriatic arthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Psoriasis is a common inflammatory disease of the skin and joints with a prevalence of 1-3% in the caucasian population of Northern Europe and the US. Similarly to other inflammatory diseases there is now substantial and accumulating evidence that psoriasis has a systemic inflammatory component.
It is known that patients suffering from psoriasis have increased prevalence of traditional cardiovascular risk factors, such as hypertension, dyslipidaemia, obesity, tobacco use and diabetes mellitus. This would logically explain an increased rate of cardiovascular events, but even when adjusting for theses risk factors, psoriasis carry an independent risk for developing cardiovascular disease.
Read more
Recent large epidemiological studies have shown a strong correlation between psoriasis and myocardial infarction.
Atopic dermatitis has been linked to ischemic stroke in one study, but besides this, the disease has not been associated with cardiovascular disease.
In conclusion, convincing and increasing evidence is supporting that psoriasis induce accelerated atherosclerosis and hence cardiovascular disease and mortality. In particular, this is seen in young patients with early disease onset.
Psoriasis is believed to be driven by cytokines produced by Th1 and Th17 lymphocytes. A number of these cytokines are suggested to be atherogenic. In contrast, another chronic inflammatory disease, atopic dermatitis, is predominantly driven by Th2 lymphocyte derived cytokines, some of which may inhibit atherosclerotic processes. It is therefore, of interest to compare the presence of cardiovascular disease in these two inflammatory skin diseases.
Hypothesis: That the risk of developing cardiovascular disease and especially coronary artery disease is increased in psoriasis patients and that this process can be influenced by treatment of psoriasis with biological treatment.
- Conditions
- Psoriasis, Atopic Dermatitis, Atherosclerosis
- Being tested
- biological treatment
- Medical subject headings
- Psoriasis, Dermatitis, Atopic, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological treatmentDrug
Also called Adalimumab, Etanercept, Infliximab, Ustekinumab
patients treated with anti-psoriatic biological agents
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis topical treatment | Psoriasis topical treatment. No systemic drugs. | |
| Psoriasis biological treatment | Psoriasis biological treatment. Anti-Tnf and anti-il12/23. Receives: Drug: biological treatment | |
| Severe atopic dermatitis | Severe atopic dermatitis | |
| Control | No intervention. No inflammatory skin disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in coronary calcium score (CAC score)
Psoriasis groups evaluated at 0 and approximately 12 months. AD group and controls at baseline only.
Measured: baseline: 0 months, and follow-up: approximately 12 months
Repeated Coronary CT Angiography (CCTA)
Assessment according to the 18-segment model (as suggested by AHA): Changes in number of coronary plaques, stenosis, severity, composition. Changes in coronary plaque volume index.
Psoriasis groups evaluated at 0 and approximately 12 months. AD group and untreated controls at baseline only.
Measured: 0 and approximately 12 months
Secondary outcomes (3)
Cardiovascular risk markers
hs-crp, homocystein, SBHG, apolipoprotein B, MBL, PAPP-A.
Measured: 0, 3 and 12 months
interleukines in blood
selected cytokines (amongst: TNFα, IL-1, IL-6, IL-8, IL-10, IL-12, IL-13, IL-15, IL17A, IL-19, IL-20, IL-23, IFN, ICAM-1, E-selectin)
Measured: 0, 3 and 12 months
traditional cardiovascular risk factors
monitoring of blood cholesterol levels and blood glucose.
Measured: 0, 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Aage Bangs Fond, AbbVie, Region Midt Forskningsfond
- Responsible party
- Sponsor
- Investigators
- Kasper F Hjuler, M.D., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356758
- Sponsor's protocol ID
- j-nr 20100249
- Status last verified
- Aug 2014
- First submitted
- 9 May 2011
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hjuler KF, Bottcher M, Vestergaard C, Deleuran M, Raaby L, Botker HE, Iversen L, Kragballe K. Increased Prevalence of Coronary Artery Disease in Severe Psoriasis and Severe Atopic Dermatitis. Am J Med. 2015 Dec;128(12):1325-34.e2. doi: 10.1016/j.amjmed.2015.05.041. Epub 2015 Jun 18.
PubMed 26093174
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents
- ClinicalTrials.gov ID
- NCT01356758
- Acronym / sponsor ID
- j-nr 20100249
- Conditions
- Psoriasis, Atopic Dermatitis, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Aage Bangs Fond, AbbVie, Region Midt Forskningsfond
- Study start
- Mar 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 19 May 2011 (estimated)
- 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.
Psoriasis is a common inflammatory disease of the skin and joints with a prevalence of 1-3% in the caucasian population of Northern Europe and the US. Similarly to other inflammatory diseases there is now substantial and accumulating evidence that psoriasis has a systemic inflammatory component.
It is known that patients suffering from psoriasis have increased prevalence of traditional cardiovascular risk factors, such as hypertension, dyslipidaemia, obesity, tobacco use and diabetes mellitus. This would logically explain an increased rate of cardiovascular events, but even when adjusting for theses risk factors, psoriasis carry an independent risk for developing cardiovascular disease.
Recent large epidemiological studies have shown a strong correlation between psoriasis and myocardial infarction.
Atopic dermatitis has been linked to ischemic stroke in one study, but besides this, the disease has not been associated with cardiovascular disease.
In conclusion, convincing and increasing evidence is supporting that psoriasis induce accelerated atherosclerosis and hence cardiovascular disease and mortality. In particular, this is seen in young patients with early disease onset.
Psoriasis is believed to be driven by cytokines produced by Th1 and Th17 lymphocytes. A number of these cytokines are suggested to be atherogenic. In contrast, another chronic inflammatory disease, atopic dermatitis, is predominantly driven by Th2 lymphocyte derived cytokines, some of which may inhibit atherosclerotic processes. It is therefore, of interest to compare the presence of cardiovascular disease in these two inflammatory skin diseases.
Hypothesis: That the risk of developing cardiovascular disease and especially coronary artery disease is increased in psoriasis patients and that this process can be influenced by treatment of psoriasis with biological treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Psoriasis topical treatment | – | –Psoriasis topical treatment. No systemic drugs. |
| Psoriasis biological treatment | – | Drug: biological treatmentPsoriasis biological treatment. Anti-Tnf and anti-il12/23. |
| Severe atopic dermatitis | – | –Severe atopic dermatitis |
| Control | – | –No intervention. No inflammatory skin disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe psoriasis recruited from a dermatological in- and out patient clinic. Patients with severe atopic dermatitis.
Key inclusion criteria (3 listed)
- Males and females aged 18 years or above.
- Intervention group: Severe plaque psoriasis with indication for biological therapy according to national guidelines. Psoriasis Control group: Patients with similar disease activity who for personal reasons decline systemic treatment and only receive topical therapy. Atopic dermatitis group: Patients matched regarding sex, disease duration, body surface involvement, BMI and smoking habits.
- Signed informed consent form prior to initiation of any study-mandated procedure.
Key exclusion criteria (10 listed)
- Significant arterial hypertension, unless well controlled with anti-hypertensive medication for at least 1 month before inclusion.
- Lipid-lowering treatment, unless well controlled for at least 1 month before inclusion.
- Congestive heart failure (NYHA group III and IV).
- Reduced kidney function (eGFR below 60).
- Oral methotrexate, ciclosporin, acitretin and fumarate esters within 1 month before inclusion. In the intervention group, patients receiving oral anti-psoriatic treatment for at least 6 months before the study start can be included, if they are maintained on the same dose during the study period.
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 |
|---|---|---|
| biological treatmentAlso: Adalimumab, Etanercept, Infliximab, Ustekinumabpatients treated with anti-psoriatic biological agents | Drug | Psoriasis biological treatment |
Primary outcome
Change in coronary calcium score (CAC score)
Time frame: baseline: 0 months, and follow-up: approximately 12 months
Psoriasis groups evaluated at 0 and approximately 12 months. AD group and controls at baseline only.
Repeated Coronary CT Angiography (CCTA)
Time frame: 0 and approximately 12 months
Assessment according to the 18-segment model (as suggested by AHA): Changes in number of coronary plaques, stenosis, severity, composition. Changes in coronary plaque volume index. Psoriasis groups evaluated at 0 and approximately 12 months. AD group and untreated controls at baseline only.
3 secondary outcomes
Cardiovascular risk markers
Time frame: 0, 3 and 12 months
interleukines in blood
Time frame: 0, 3 and 12 months
traditional cardiovascular risk factors
Time frame: 0, 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Derived from this study: PubMed 26093174Hjuler KF, Bottcher M, Vestergaard C, Deleuran M, Raaby L, Botker HE, Iversen L, Kragballe K. Increased Prevalence of Coronary Artery Disease in Severe Psoriasis and Severe Atopic Dermatitis. Am J Med. 2015 Dec;128(12):1325-34.e2. doi: 10.1016/j.amjmed.2015.05.041. Epub 2015 Jun 18.
- Individual participant dataSharing planned: Undecided
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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.
Kasper F Hjuler, M.D. principal investigator
Aarhus University Hospital
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 Psoriasis and Atopic Dermatitis, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 21 Dec 2015. 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 Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in coronary calcium score (CAC score) (time frame: baseline: 0 months, and follow-up: approximately 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01356758, which also lists 1 linked publication.
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 21 Dec 2015.