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Phase 2 N=24 Randomized Triple-blind Treatment

Etanercept and Vascular Function in Psoriasis

PSORIASIS

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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