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Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study (MMAPPS)

This study is currently recruiting participants.
Verified November 2012 by Massachusetts General Hospital
Sponsor:
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01522742
First received: December 29, 2011
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study

Resource links provided by NLM:

Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET. [ Time Frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel). ] [ Designated as safety issue: No ]
    Degree of aortic/coronary atherosclerotic plaque inflammation assessed via cardiac FDG-PET as target to background ratio (TBR) of the standardized uptake value (SUV).


Secondary Outcome Measures:
  • Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography. [ Time Frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel). ] [ Designated as safety issue: No ]
    Burden of aortic/coronary atherosclerotic plaque as measured by MDCT coronary angiography.

  • Aortic/coronary atherosclerotic plaque morphology on MDCT coronary angiography. [ Time Frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel). ] [ Designated as safety issue: No ]
    Morphology of the aortic/coronary atherosclerotic plaque (e.g. calcification score, vulnerability characteristics) as measured by MDCT coronary angiography.

  • Endothelial function as measured by flow-mediated vasodilation. [ Time Frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel). ] [ Designated as safety issue: No ]
  • Oral glucose tolerance. [ Time Frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel). ] [ Designated as safety issue: No ]
    Blood sugar and insulin levels during a standard 2-hour oral glucose tolerance test.

  • Lipid and lipoprotein levels. [ Time Frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel). ] [ Designated as safety issue: No ]
    Levels of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B, apolipoprotein C-II, apolipoprotein C-III, and apolipoprotein E.

  • Inflammatory biomarker levels. [ Time Frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel). ] [ Designated as safety issue: No ]
    Levels of inflammatory biomarkers including but not limited to high-sensitivity C-reactive protein, interleukin-6, and TNF-alpha.

  • Body fat distribution. [ Time Frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel). ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Plasma, serum.


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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 12 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522742

Contacts
Contact: Steven K Grinspoon, MD 617-724-9109 sgrinspoon@partners.org
Contact: Markella V Zanni, MD 617-724-6926 mzanni@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven K Grinspoon, MD     617-724-9109     sgrinspoon@partners.org    
Contact: Markella V. Zanni, MD     617-724-6926     mzanni@partners.org    
Principal Investigator: Steven K Grinspoon, MD            
Sub-Investigator: Markella V Zanni, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Immunex Corporation
Investigators
Principal Investigator: Steven K Grinspoon, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Steven K. Grinspoon, MD, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01522742     History of Changes
Other Study ID Numbers: 2011P-000557
Study First Received: December 29, 2011
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
psoriasis
cardiovascular disease risk
atherosclerosis
etanercept (enbrel)

Additional relevant MeSH terms:
Atherosclerosis
Psoriasis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013