Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Psoriasis Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| Adalimumab | Adalimumab will be given in a dose of 40 mg subcutaneously every other week. |
| |
| Acitretin | Acetretin will be prescribed as daily with 25mg if the patient is <80Kg or 35mg if the patient is >80Kg. |
| |
| UVB Excimer Laser |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Subjects will receive Methotrexate as detailed in the "Group" description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker assessment | 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. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in coronary artery calcification scoring | Coronary Artery Calcification Scoring (CACS) will be performed at the first and final visits for the study. | 52 weeks |
| Changes in PET-MRI | 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. |
Not provided
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):
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:
Not provided
Not provided
Psoriasis patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Neil Korman, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20713833 | Background | 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. | |
| 19925489 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D000069549 | Ustekinumab |
| D000068800 | Etanercept |
| D000068879 | Adalimumab |
| D017255 | Acitretin |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Skin biopsies and blood samples will be collected
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. |
|
| 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. |
|
| 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. |
|
| 52 weeks |
| Clinical improvement | Psoriasis Area Severity Index (PASI) and Static Physician Global Assessment (sPGA) will be performed throughout the study to monitor clinical improvement. | 52 weeks |
| Changes in skin biopsies | 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. | 52 weeks |
| 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. |
| 17986302 | Background | 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. |
| 12917302 | Background | 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. |
| 18355421 | Background | 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. |
| 20066450 | Background | 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. |
| 18047523 | Background | 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. |
| 21576552 | Background | 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. |
| 22508874 | Background | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |