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Trial record 27 of 31 for:    ACITRETIN

Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

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ClinicalTrials.gov Identifier: NCT02330380
Recruitment Status : Completed
First Posted : January 1, 2015
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
National Psoriasis Foundation
Information provided by (Responsible Party):
Neil Korman, University Hospitals Cleveland Medical Center

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.


Condition or disease Intervention/treatment
Psoriasis Inflammation Drug: Methotrexate Drug: Ustekinumab Drug: Etanercept Drug: Adalimumab Drug: Acitretin Other: UVB Excimer Laser Other: Narrowband UVB

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
Actual Study Start Date : April 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Skin biopsies and blood samples will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Psoriasis patients
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330380


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
National Psoriasis Foundation
Investigators
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Principal Investigator: Neil Korman, MD University Hospitals Cleveland Medical Center

Publications:

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Responsible Party: Neil Korman, Principal Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02330380     History of Changes
Other Study ID Numbers: 04-13-21
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Keywords provided by Neil Korman, University Hospitals Cleveland Medical Center:
psoriasis, comparative effects, inflammation
Additional relevant MeSH terms:
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Acitretin
Psoriasis
Inflammation
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Etanercept
Methotrexate
Ustekinumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents