Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study

NCT01522742 | Terminated

• 1 other identifier: 2011P-000557
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

psoriasis; cardiovascular disease risk; atherosclerosis; etanercept (enbrel)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography.

  Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).

• Aortic/coronary atherosclerotic plaque morphology on MDCT coronary angiography.

  Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).

• 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).

• Oral glucose tolerance.

  Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).

• Lipid and lipoprotein levels.

  Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).

Study Arms (2)

Healthy control subjects

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

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• men and women age 18-80 without psoriasis
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Immunex Corporation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum.

MeSH Terms

Conditions

Psoriasis; Atherosclerosis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Steven K Grinspoon, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: February 1, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

US (1)