Etanercept and Vascular Function in Psoriasis

NCT01989689 | Completed Phase 2 Results DMC

• 1 other identifier: IRB00039574
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PSORIASIS

Keywords

PSORIASIS

Outcome Measures

Primary Outcomes (3)

• Vascular Function as Measured by Brachial Artery Flow-mediated Dilation (FMD)

  Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.

  Baseline

• Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)

  Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter - 3 month diameter)/3 month diameter × 100.

  3 months

• Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)

  Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter - 6 month diameter)/6 month diameter × 100.

  6 months

Study Arms (2)

Etanercept/Placebo

EXPERIMENTAL

The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.

Drug: Etanercept; Drug: Placebo

Placebo/Etanercept

ACTIVE COMPARATOR

The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.

Drug: Etanercept; Drug: Placebo

Interventions

Etanercept DRUG

Etanercept 50mg twice weekly

Also known as: Enbrel

Etanercept/Placebo; Placebo/Etanercept

Placebo DRUG

Etanercept/Placebo; Placebo/Etanercept

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Emory University: lead
• Amgen: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Arshed Ali Quyyumi MD/FACC
• Organization: Emory University

aquyyum@emory.edu

404-727-3655

Study Officials

• Arshed A Quyyumi, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 21, 2013
• Study Start: August 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 19, 2014
• Results First Posted: December 19, 2014

Record last verified: 2014-12

Locations

US (1)