Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Aarhus
Sponsor:
Collaborators:
Aarhus University Hospital
Aage Bangs Fond
AbbVie
Region Midt Forskningsfond
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01356758
First received: May 9, 2011
Last updated: June 17, 2014
Last verified: May 2014
  Purpose

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.

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.


Condition Intervention
Psoriasis
Atherosclerosis
Drug: biological treatment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Coronary calcium score [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
    both calcified and soft plaques will be evaluated


Secondary Outcome Measures:
  • Cardiovascular risk markers [ Time Frame: 0, 3 and 12 months ] [ Designated as safety issue: No ]
    hs-crp, homocystein, SBHG, apolipoprotein B, MBL, PAPP-A.

  • interleukines in blood [ Time Frame: 0, 3 and 12 months ] [ Designated as safety issue: No ]
    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)

  • traditional cardiovascular risk factors [ Time Frame: 0, 3 and 12 months ] [ Designated as safety issue: No ]
    monitoring of blood cholesterol levels and blood glucose.


Biospecimen Retention:   Samples With DNA

blood and skin samples.


Estimated Enrollment: 90
Study Start Date: March 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Psoriasis topical treatment
Psoriasis topical treatment. No systemic drugs.
Psoriasis biological treatment
Psoriasis biological treatment. Anti-Tnf and anti-il12/23.
Drug: biological treatment
patients treated with anti-psoriatic biological agents
Other Names:
  • Adalimumab
  • Etanercept
  • Infliximab
  • Ustekinumab
Severe atopic dermatitis
Severe atopic dermatitis
Control
No intervention. No inflammatory skin disease.

  Eligibility

Ages Eligible for Study:   28 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with severe psoriasis recruited from a dermatological in- and out patient clinic

Criteria

Inclusion Criteria:

  1. Males and females aged 18 years or above.
  2. 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 control group: Patients matched regarding sex, disease duration, body surface involvement, BMI and smoking habits.
  3. Signed informed consent form prior to initiation of any study-mandated procedure.

Exclusion Criteria:

  1. Significant arterial hypertension, unless well controlled with anti-hypertensive medication for at least 1 month before inclusion.
  2. Lipid-lowering treatment, unless well controlled for at least 1 month before inclusion.
  3. Congestive heart failure (NYHA group III and IV).
  4. Reduced kidney function (eGFR below 60).
  5. 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.
  6. UVB phototherapy and PUVA photochemotherapy within 1 month prior to study start.
  7. Prior treatment with infliximab, etanercept, adalimumab or ustekinumab unless less than PASI-50% reduction have been observed during this treatment.
  8. Investigational biological agents within 6 months prior to inclusion.
  9. Any other investigational drug within 1 month or 5 half lives prior to inclusion, which ever is longer.
  10. Concurrent immunosuppressive or anti-inflammatory treatment for immune diseases other than psoriasis and psoriatic arthritis.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356758

Contacts
Contact: Kasper F Hjuler, M.D. +4578461907 khp@ki.au.dk
Contact: M Larsen, Secr. mettelar@rm.dk

Locations
Denmark
Dep. of Dermatology Recruiting
Aarhus C, Denmark, 8000
Principal Investigator: Kasper F Hjuler, M.D.         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Aage Bangs Fond
AbbVie
Region Midt Forskningsfond
Investigators
Principal Investigator: Kasper F Hjuler, M.D. Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01356758     History of Changes
Other Study ID Numbers: j-nr 20100249
Study First Received: May 9, 2011
Last Updated: June 17, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics / Central Denmark Region Committees on Biomedical Research Ethics, IORG-number: 0005129
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Atherosclerosis
Psoriasis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014