Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study

Psoriasis Clinical Trial

— MMAPPS  

Official title:

Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01522742
• Other study ID #: 2011P-000557
• Status: Terminated
• Phase: N/A
• First received: December 29, 2011
• Last updated: March 15, 2017
• Start date: February 2012
• Est. completion date: January 2016

Study information

• Verified date: March 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Psoriasis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Immunex Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET.	Degree of aortic/coronary atherosclerotic plaque inflammation assessed via cardiac FDG-PET as target to background ratio (TBR) of the standardized uptake value (SUV).	Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Secondary	Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography.	Burden of aortic/coronary atherosclerotic plaque as measured by MDCT coronary angiography.	Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Secondary	Aortic/coronary atherosclerotic plaque morphology on MDCT coronary angiography.	Morphology of the aortic/coronary atherosclerotic plaque (e.g. calcification score, vulnerability characteristics) as measured by MDCT coronary angiography.	Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Secondary	Endothelial function as measured by flow-mediated vasodilation.		Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Secondary	Oral glucose tolerance.	Blood sugar and insulin levels during a standard 2-hour oral glucose tolerance test.	Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Secondary	Lipid and lipoprotein levels.	Levels of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B, apolipoprotein C-II, apolipoprotein C-III, and apolipoprotein E.	Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Secondary	Inflammatory biomarker levels.	Levels of inflammatory biomarkers including but not limited to high-sensitivity C-reactive protein, interleukin-6, and TNF-alpha.	Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Secondary	Body fat distribution.	Measurements of height, weight, waist-to-hip ratio, leg circumference, arm circumference, and neck circumference. Determinations by whole body DEXA scanning of the total body and regional percent fat and lean body mass. Determination by single-slice abdominal computed tomography of total fat area, visceral adipose tissue, and subcutaneous adipose tissue.	Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).