Etanercept and Vascular Function in Psoriasis

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators plan to measure the health of the vascular system of subjects taking Etanercept for the treatment of plaque psoriasis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Amgen
• Treatments: Etanercept

Criteria

Inclusion Criteria:

• Male or non-pregant females aged 21-70 years.

• Diagnosis of moderate to severe plaque psoriasis

• Concomitant therapy: Patients will be allowed to be on concomitant therapy with aspirin, statins, thiazide diuretics, calcium antagonists (for treatment - of hypertension), clonidine, or vasodilators. Patients will be on stable medical therapy for at least 3 months before recruitment.

Exclusion Criteria:

• Uncontrolled cardiac risk factors (hypertension, hypercholesterolemia, smoking, diabetes)

• Symptomatic coronary or peripheral atherosclerotic vascular disease

• Current anti-TNF therapy with etanercept or infliximab or therapy in the previous 3 months

• Presence of psoriatic plaque or other skin condition on the volar surface of the forearms which may interfere with vascular ultrasonography

• Pregnancy, Breast feeding

• Active substance abuse

• Other inflammatory condition or malignancy

• Renal failure [creatinine > 2.5mg/dL] or liver failure (Liver enzymes > 2x normal)

• Current use of COX-2 inhibitors

• Inability to give informed consent

• Prednisone dosage > 7.5mg/day

• Statins, anti diabetes medications, and aspirin will be continued if the patient is on stable therapy for at least 3 months, and all medications will be continued without alteration of doses during the study period.

• Antibiotic administration within 1 week of study drug initiation or active severe infection within 4 weeks of study screening

• Active guttate, erythrodermic or pustular psoriasis

• Systemic psoriasis therapy or psoralen plus ultraviolet (UV) A phototherapy for 4 weeks before initiation of study