Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

Inflammation Clinical Trial

Official title:

Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330380
• Other study ID #: 04-13-21
• Status: Completed
• Phase: N/A
• First received: December 30, 2014
• Last updated: October 12, 2017
• Start date: April 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inflammation
• Psoriasis

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	National Psoriasis Foundation

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

Flytström 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. Epub 2007 Nov 6. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. Review. — View 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. Epub 2007 Nov 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	52 weeks
Secondary	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
Secondary	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