Etanercept and Vascular Function in Psoriasis
Completed · Phase 2 · Has a placebo group
Conditions studied: PSORIASIS
In brief
The investigators plan to measure the health of the vascular system of subjects taking Etanercept for the treatment of plaque psoriasis.
Key facts
- Study ID
- NCT01989689
- Run by
- Emory University
- People needed
- 24
- Starts
- 2010-08-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2014-12-19
Who can join
Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Emory University — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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