Status:
TERMINATED
Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Immunex Corporation
Conditions:
Psoriasis
Eligibility:
All Genders
18-80 years
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) ...
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 subje...
Eligibility Criteria
Inclusion
- FOR PSORIASIS PATIENTS
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01522742
Start Date
February 1 2012
End Date
January 1 2016
Last Update
March 17 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114