Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

October 12, 2017 updated by: Neil Korman, University Hospitals Cleveland Medical Center

This is a prospective longitudinal observational pilot study of psoriasis patients on continuous standard-of-care systemic therapeutics to determine the level of change in established (plasma/serum) and investigative (cellular) biomarkers that are associated with increased risk of CVD events.

The final endpoint of the proposed study will be a ranking of the examined biomarkers based upon an integrated assessment of biomarker behavior over time.

Secondary outcomes will assess changes in coronary artery calcification scoring, PET-MRI, skin biopsies, and clinical improvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Psoriasis patients

Description

Inclusion Criteria:

  • Subjects ages 18-65 years old
  • Diagnosis of moderate-to-severe plaque psoriasis
  • Plaque affects ≥ 10% of subject's body surface area (BSA)
  • Subjects prescribed one of the following standard-of-care treatments for their psoriasis: Ustekinumab, Methotrexate, Etanercept, Adalimumab, Narrow Band UVB (311nm), Excimer Laser Treatment (308nm), or Acitretin

  • Subjects willing to complete a Washout Period prior to Visit 1 (only for subjects currently on a psoriasis treatment):

    • Discontinue systemic therapies for at least 4 weeks
    • Discontinue topical therapies for at least 2 weeks
    • Discontinue phototherapies for at least 2 weeks

Exclusion Criteria:

  • Subjects who are currently on a psoriasis treatment and unwilling to go through the washout-period
  • Subjects with a critical illness or who are immunocompromised
  • Weight is 400lbs or greater
  • Subjects who are currently pregnant or breastfeeding
  • Subjects who have metal implants
  • Subjects who have a pacemaker, stent, or artificial heart valve
  • History of clinically significant hematological, renal or liver disease

  • Patients with known co-morbidities that raise biomarkers such as:

    • History of myocardial infarction (MI)
    • History of cerebrovascular accident (CVA)
    • Significant atherosclerosis (defined as the presence of any carotid plaque; or carotid intimal media thickness (cIMT) >75th percentile for age; or the presence of coronary artery calcium score>100)
    • Poorly controlled diabetes (elevated HbA1c > 8.5)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Methotrexate
Methotrexate will be dosed weekly. Methotrexate is given as a single, weekly dose and is will be started at 15mg after a first week test dose of 2.5 mg to minimize side effects and achieve efficacy. Weekly dosages will be 15mg.
Drug: Methotrexate
Subjects will receive Methotrexate as detailed in the "Group" description.
Ustekinumab
Ustekinumab is given as a subcutaneous injection of 45mg if the patient is <100Kg or 90mg if the patient is >100Kg at weeks 0, 4, 16, and every 12 weeks thereafter.
Drug: Ustekinumab
Subjects will receive Ustekinumab as detailed in the "Group" description.
Etanercept
Etanercept will be given in the first 3 months of treatment as 50 mg twice a week (3 or 4 days apart). After 3 months, a reduced dose of 50 mg will be given once per week.
Drug: Etanercept
Subjects will receive Etanercept as detailed in the "Group" description.
Adalimumab
Adalimumab will be given in a dose of 40 mg subcutaneously every other week.
Drug: Adalimumab
Subjects will receive Adalimumab as detailed in the "Group" description.
Acitretin
Acetretin will be prescribed as daily with 25mg if the patient is <80Kg or 35mg if the patient is >80Kg.
Drug: Acitretin
Subjects will receive Acitretin as detailed in the "Group" description.
UVB Excimer Laser
Dose determination will be determined by a physician per standard-of-care by performing a Sunburn Test/Minimal Erythemal Dose Test, or by visually evaluating the patient's skin type and thickness of psoriasis plaque. Initial laser dose will be 1-4X the MED depending on the thickness of the plaque. Escalation will be 25-50% increase in dose per treatment if there is no residual erythema, 25% increase per treatment if there is mild residual erythema, and 0% increase per treatment if there is moderate residual erythema. Investigators also have the option to skip a treatment, if there is above moderate erythema, or significant patient discomfort. Patients will receive treatment twice a week.
Other: UVB Excimer Laser
Subjects will receive UVB Excimer Laser therapy as detailed in the "Group" description.
Narrowband UVB
Narrowband UVB (311nm) will be used to treat patients 3X per week with 311nm of UVB light. Uninvolved areas of skin will be covered where possible to minimize excess sun exposure. Patients will be tested for their minimal erythemal dose (MED), after which, based upon Fitzpatrick Scale skin type, a patient will typically beginning with 1-2 minutes based on skin type and gradually increased by 10-15% per treatment dose as tolerated.
Other: Narrowband UVB
Subjects will receive Narrowband UVB as detailed in the "Group" description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker assessment
Time Frame: 52 weeks
The biomarkers examined throughout the study will be assessed. And, an integrated assessment of biomarker behavior over time will be performed. Biomarkers examined will include High sensitivity C-reactive protein (hsCRP), Myeloperoxidase (MPO), resistin, adiponectin and leptin.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in coronary artery calcification scoring
Time Frame: 52 weeks
Coronary Artery Calcification Scoring (CACS) will be performed at the first and final visits for the study.
52 weeks
Changes in PET-MRI
Time Frame: 52 weeks
Patients who enroll in this study will receive two PET/MRI scans. The first one will be done prior to beginning their psoriasis therapy during Visit 1 and the second PET/MRI will be done during the Final Visit.
52 weeks
Clinical improvement
Time Frame: 52 weeks
Psoriasis Area Severity Index (PASI) and Static Physician Global Assessment (sPGA) will be performed throughout the study to monitor clinical improvement.
52 weeks
Changes in skin biopsies
Time Frame: 52 weeks
In some patients, two 4-6mm punch biopsies will be obtained after the washout period has been observed, one from a psoriasis lesion and one from an adjacent, uninvolved area. Two 4-6mm punch biopsies will also be obtained during the final visit, one from a psoriasis lesion and one from an adjacent, uninvolved area.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

National Psoriasis Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 30, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (Estimate)

January 1, 2015

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-13-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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