Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study

NCT ID: NCT01522742

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-01-31

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.

Conditions

Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy control subjects

Healthy control subjects matched to psoriasis patients on traditional cardiovascular risk factors will be studied at baseline.

No interventions assigned to this group

Psoriasis patients starting etanercept

Patients with moderate to severe psoriasis with or without arthritis who are about to be started on etanercept (enbrel) by their treating clinicians will be studied at baseline and 3 months after etanercept therapy.

No interventions assigned to this group

Eligibility Criteria

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

-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 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Immunex Corporation

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steven K. Grinspoon, MD

Professor of Medicine, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven K Grinspoon, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2011P-000557

Identifier Type: -

Identifier Source: org_study_id