Phase 2
N=24
Etanercept and Vascular Function in Psoriasis
PSORIASIS
Bottom Line
View on ClinicalTrials.gov: NCT01989689 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Vascular Function as Measured by Brachial Artery Flow-mediated Dilation (FMD) — 9.71; 11.15 percentage of brachial artery diameter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Etanercept (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vascular Function as Measured by Brachial Artery Flow-mediated Dilation (FMD) |
9.71; 11.15 | — |
| PRIMARY Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD) |
8.34; 7.73 | — |
| PRIMARY Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD) |
8.34; 7.73 | — |
Summary
The investigators plan to measure the health of the vascular system of subjects taking Etanercept for the treatment of plaque psoriasis.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01989689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.