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

This study is currently recruiting participants.
Verified April 2013 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: April 3, 2013
Last verified: April 2013

May 9, 2011
April 3, 2013
March 2011
December 2013   (final data collection date for primary outcome measure)
Coronary calcium score [ Time Frame: 0 and 12 months ] [ Designated as safety issue: No ]
both calcified and soft plaques will be evaluated
Same as current
Complete list of historical versions of study NCT01356758 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
    selcted 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.
Not Provided
Not Provided
 
Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents
Cardiovascular Risk Assessment in Patients With Severe Psoriasis Treated With Biologic Agents

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood and skin samples.

Non-Probability Sample

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

  • Psoriasis
  • Atherosclerosis
Drug: biological treatment
patients treated with anti-psoriatic biological agents
Other Names:
  • Adalimumab
  • Etanercept
  • Infliximab
  • Ustekinumab
  • Psoriasis topical treatment
    Psoriasis topical treatment. No systemic drugs.
  • Psoriasis biological treatment
    Psoriasis biological treatment. Anti-Tnf and anti-il12/23.
    Intervention: Drug: biological treatment
  • Severe atopic dermatitis
    Severe atopic dermatitis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
September 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Kasper F Hjuler, M.D. +4578461905 khp@ki.au.dk
Denmark
 
NCT01356758
j-nr 20100249
No
University of Aarhus
University of Aarhus
  • Aarhus University Hospital
  • Aage Bangs Fond
  • AbbVie
  • Region Midt Forskningsfond
Principal Investigator: Kasper F Hjuler, M.D. Aarhus University Hospital
University of Aarhus
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP