Clinical trial NCT02330380: Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
Official title: Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Inflammation
Keywords: psoriasis, comparative effects, inflammation
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: National Psoriasis Foundation
First posted: 2015-01-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Psoriasis patients

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Biomarker assessment
timeFrame: 52 weeks
Secondary outcomes:
measure: Changes in coronary artery calcification scoring
timeFrame: 52 weeks
measure: Changes in PET-MRI
timeFrame: 52 weeks
measure: Clinical improvement
timeFrame: 52 weeks
measure: Changes in skin biopsies
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Neil Korman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alora-Palli MB, Brouda I, Green B, Kimball AB. A cost-effectiveness comparison of liquor carbonis distillate solution and calcipotriol cream in the treatment of moderate chronic plaque psoriasis. Arch Dermatol. 2010 Aug;146(8):919-22. doi: 10.1001/archdermatol.2010.167. No abstract available.
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citation: Saurat JH, Stingl G, Dubertret L, Papp K, Langley RG, Ortonne JP, Unnebrink K, Kaul M, Camez A; CHAMPION Study Investigators. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION). Br J Dermatol. 2008 Mar;158(3):558-66. doi: 10.1111/j.1365-2133.2007.08315.x. Epub 2007 Nov 28.
citation: Mehta NN, Yu Y, Saboury B, Foroughi N, Krishnamoorthy P, Raper A, Baer A, Antigua J, Van Voorhees AS, Torigian DA, Alavi A, Gelfand JM. Systemic and vascular inflammation in patients with moderate to severe psoriasis as measured by [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG-PET/CT): a pilot study. Arch Dermatol. 2011 Sep;147(9):1031-9. doi: 10.1001/archdermatol.2011.119. Epub 2011 May 16.
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