Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT02330380
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 30, 2013
Status verified
Oct 2017
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
26 participants (actual)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: Adalimumab
    Adalimumab will be given in a dose of 40 mg subcutaneously every other week.
  • Arm: Acitretin
    Acetretin will be prescribed as daily with 25mg if the patient is \<80Kg or 35mg if the patient is \>80Kg.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Biomarker assessment [ Time Frame: 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106-

Find similar trials in Cleveland, OH

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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