Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
NCT ID: NCT02330380
Last Updated: 2017-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26 participants
OBSERVATIONAL
2013-04-30
2016-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Narrowband UVB
Subjects will receive Narrowband UVB as detailed in the "Group" description.
Interventions
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Methotrexate
Subjects will receive Methotrexate as detailed in the "Group" description.
Ustekinumab
Subjects will receive Ustekinumab as detailed in the "Group" description.
Etanercept
Subjects will receive Etanercept as detailed in the "Group" description.
Adalimumab
Subjects will receive Adalimumab as detailed in the "Group" description.
Acitretin
Subjects will receive Acitretin as detailed in the "Group" description.
UVB Excimer Laser
Subjects will receive UVB Excimer Laser therapy as detailed in the "Group" description.
Narrowband UVB
Subjects will receive Narrowband UVB as detailed in the "Group" description.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
65 Years
ALL
No
Sponsors
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National Psoriasis Foundation
OTHER
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Neil Korman
Principal Investigator
Principal Investigators
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Neil Korman, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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References
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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.
Ho SG, Yeung CK, Chan HH. Methotrexate versus traditional Chinese medicine in psoriasis: a randomized, placebo-controlled trial to determine efficacy, safety and quality of life. Clin Exp Dermatol. 2010 Oct;35(7):717-22. doi: 10.1111/j.1365-2230.2009.03693.x.
Flytstrom I, Stenberg B, Svensson A, Bergbrant IM. Methotrexate vs. ciclosporin in psoriasis: effectiveness, quality of life and safety. A randomized controlled trial. Br J Dermatol. 2008 Jan;158(1):116-21. doi: 10.1111/j.1365-2133.2007.08284.x. Epub 2007 Nov 6.
Heydendael VM, Spuls PI, Opmeer BC, de Borgie CA, Reitsma JB, Goldschmidt WF, Bossuyt PM, Bos JD, de Rie MA. Methotrexate versus cyclosporine in moderate-to-severe chronic plaque psoriasis. N Engl J Med. 2003 Aug 14;349(7):658-65. doi: 10.1056/NEJMoa021359.
Reich K, Sinclair R, Roberts G, Griffiths CE, Tabberer M, Barker J. Comparative effects of biological therapies on the severity of skin symptoms and health-related quality of life in patients with plaque-type psoriasis: a meta-analysis. Curr Med Res Opin. 2008 May;24(5):1237-54. doi: 10.1185/030079908x291985. Epub 2008 Mar 19.
Atteno M, Peluso R, Costa L, Padula S, Iervolino S, Caso F, Sanduzzi A, Lubrano E, Del Puente A, Scarpa R. Comparison of effectiveness and safety of infliximab, etanercept, and adalimumab in psoriatic arthritis patients who experienced an inadequate response to previous disease-modifying antirheumatic drugs. Clin Rheumatol. 2010 Apr;29(4):399-403. doi: 10.1007/s10067-009-1340-7.
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.
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.
Gelfand JM, Wan J, Callis Duffin K, Krueger GG, Kalb RE, Weisman JD, Sperber BR, Stierstorfer MB, Brod BA, Schleicher SM, Bebo BF Jr, Troxel AB, Shin DB, Steinemann JM, Goldfarb J, Yeung H, Van Voorhees AS. Comparative effectiveness of commonly used systemic treatments or phototherapy for moderate to severe plaque psoriasis in the clinical practice setting. Arch Dermatol. 2012 Apr;148(4):487-94. doi: 10.1001/archdermatol.2012.370.
Other Identifiers
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04-13-21
Identifier Type: -
Identifier Source: org_study_id