Clinical trial NCT01522742: Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study
Official title: Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Psoriasis
Keywords: psoriasis
cardiovascular disease risk
atherosclerosis
etanercept (enbrel)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Immunex Corporation
First posted: 2012-02-01
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with moderate-to-severe psoriasis with or without arthritis will be recruited primarily from dermatology and rheumatology clinics in the eastern Massachusetts area.

Brief summary: The main aims of this study are to determine whether: a) psoriasis patients with or without arthritis have more cardiovascular inflammation than healthy subjects and b)3 months of etanercept (enbrel) therapy (prescribed to psoriasis patients with or without arthritis by their treating clinicians) will decrease cardiovascular inflammation.

Detailed description: Psoriasis is a common disease characterized by skin lesions and systemic inflammation with or without arthritis. Patients with psoriasis have a higher risk of cardiovascular disease than healthy subjects, and this may be related in part to the inflammatory nature of their disease. This study is intended to help provide explanations for the increased cardiovascular disease risk in psoriasis and to assess whether this risk can be reduced by biologic anti-inflammatory therapies prescribed to resolve skin lesions and arthritis.

Eligibility criteria: FOR PSORIASIS PATIENTS

Inclusion Criteria:

-men and women age 18-80 with moderate-to-severe psoriasis (with or without arthritis) newly initiating biologic therapy with etanercept (enbrel) 50 mg once or twice weekly

Exclusion Criteria:

* pregnancy or breastfeeding
* women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
* history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease other than psoriasis or a related psoriatic condition
* previous therapy for psoriasis with a biologic agent within the past 4 months
* new initiation of a statin or antihyperglycemic agent within the past 3 months
* screening hemoglobin \< 11
* conditions which would make MDCT coronary angiography/ cardiac FDG-PET protocol unsafe or unfeasible including: significant renal dysfunction with an eGFR by Cockcroft-Gault equation of \<60 ml/min, contrast dye allergy, contraindication to beta-blockers (e.g. severe asthma, hypotension, or heart block), or contraindication to nitroglycerin (uninterruptable administration of phosphodiesterase inhibitors), body weight greater than 320 lbs (PET scanner table limitation)
* report by subject of any significant radiation exposure over the course of the year prior to enrollment; significant exposure is defined as:

  * more than 2 myocardial perfusion studies within the past 12 months
  * more than 2 CT angiograms within the past 12 months
* concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding

FOR HEALTHY CONTROL SUBJECTS

Inclusion Criteria:

-men and women age 18-80 without psoriasis

Exclusion Criteria:

* pregnancy or breastfeeding
* women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
* history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease
* screening hemoglobin \< 11
* conditions which would make MDCT coronary angiography/ cardiac FDG-PET protocol unsafe or unfeasible including: significant renal dysfunction with an estimated creatinine clearance by Cockcroft-Gault equation of \<60 ml/min, contrast dye allergy, contraindication to beta-blockers (e.g. severe asthma, hypotension, or heart block), or contraindication to nitroglycerin (e.g. continuous administration of phosphodiesterase inhibitors), body weight greater than 320 lbs PET scanner table limitation)
* report by subject of any significant radiation exposure over the course of the year prior to enrollment; significant exposure is defined as:

  * more than 2 myocardial perfusion studies within the past 12 months
  * more than 2 CT angiograms within the past 12 months
* concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding

Primary outcomes:
measure: Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET.
timeFrame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Secondary outcomes:
measure: Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography.
timeFrame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
measure: Aortic/coronary atherosclerotic plaque morphology on MDCT coronary angiography.
timeFrame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
measure: Endothelial function as measured by flow-mediated vasodilation.
timeFrame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
measure: Oral glucose tolerance.
timeFrame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
measure: Lipid and lipoprotein levels.
timeFrame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
measure: Inflammatory biomarker levels.
timeFrame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
measure: Body fat distribution.
timeFrame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven K Grinspoon, MD
role: PRINCIPAL_INVESTIGATOR
References: