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Completed

NCT Number: NCT02330380

Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

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.

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Key information

Conditions

Psoriasis Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

methotrexate

Drug

Subjects will receive Methotrexate as detailed in the "Group" description.

Ustekinumab

Drug

Subjects will receive Ustekinumab as detailed in the "Group" description.

etanercept

Drug

Subjects will receive Etanercept as detailed in the "Group" description.

Adalimumab

Drug

Subjects will receive Adalimumab as detailed in the "Group" description.

acitretin

Drug

Subjects will receive Acitretin as detailed in the "Group" description.

UVB Excimer Laser

Other

Subjects will receive UVB Excimer Laser therapy as detailed in the "Group" description.

Narrowband UVB

Other

Subjects will receive Narrowband UVB as detailed in the "Group" description.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • National Psoriasis Foundation

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2015
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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