An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis
NCT ID: NCT02174367
Last Updated: 2017-08-04
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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UNKNOWN
400 participants
OBSERVATIONAL
2012-11-30
2021-07-31
Brief Summary
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1. Establish prevalence of and factors contributing to fatty liver disease and liver fibrosis in patients with psoriasis.
Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy or non-invasive tests of fibrosis including transient elastography, ultrasound, serum markers of fibrosis including procollagen-3-N-terminal peptide (P3NP).
2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP.
3. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic syndrome on response to treatment in patients with psoriasis.
Data on co-morbid disease collected through questionnaires and review of medical records. Response to treatment assessed using psoriasis area and severity index (PASI) physician global assessment (PGA) and dermatology life quality index (DLQI).
* Study population: 380 patients with moderate to severe psoriasis will be prospectively recruited to the study.
* Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine Smith
* Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St Thomas Hospitals Trust
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Psoriasis
Patients with moderate to sever psoriasis attending a tertiary referral center. patients will be evaluated with a questionnaire, measurement of height,weight, waist circumference, fasting bloods, abdominal ultrasound and transient elastography.
Transient elastography
a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis
Interventions
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Transient elastography
a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past.
* 18 yrs. of age
Exclusion Criteria
* Patients under 18 yrs. of age
* Patients with a PASI less than 10.
* Pregnant women
18 Years
100 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
King's College London
OTHER
Responsible Party
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Principal Investigators
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Jonathan N Barker, BSC MD FRCP
Role: PRINCIPAL_INVESTIGATOR
King's College London
Catherine H Smith, MD FRCP
Role: STUDY_DIRECTOR
Guys and St Thomas' Hospitals Foundation Trust and King's College London
Locations
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Guys and St Thomas NHS Foundation trust and King's College London
London, , United Kingdom
Countries
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References
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Maybury CM, Jabbar-Lopez ZK, Wong T, Dhillon AP, Barker JN, Smith CH. Methotrexate and liver fibrosis in people with psoriasis: a systematic review of observational studies. Br J Dermatol. 2014 Jul;171(1):17-29. doi: 10.1111/bjd.12941. Epub 2014 Jul 15.
Maybury CM, Samarasekera E, Douiri A, Barker JN, Smith CH. Diagnostic accuracy of noninvasive markers of liver fibrosis in patients with psoriasis taking methotrexate: a systematic review and meta-analysis. Br J Dermatol. 2014 Jun;170(6):1237-47. doi: 10.1111/bjd.12905.
Samarasekera EJ, Smith CH; National Institute of Health and Care Excellence; Royal College of Physicians. Psoriasis: guidance on assessment and referral. Clin Med (Lond). 2014 Apr;14(2):178-82. doi: 10.7861/clinmedicine.14-2-178.
Smith CH, Barker JN. Psoriasis and its management. BMJ. 2006 Aug 19;333(7564):380-4. doi: 10.1136/bmj.333.7564.380. No abstract available.
Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
Boehncke WH, Boehncke S, Schon MP. Managing comorbid disease in patients with psoriasis. BMJ. 2010 Jan 15;340:b5666. doi: 10.1136/bmj.b5666. No abstract available.
Fonia A, Jackson K, Lereun C, Grant DM, Barker JN, Smith CH. A retrospective cohort study of the impact of biologic therapy initiation on medical resource use and costs in patients with moderate to severe psoriasis. Br J Dermatol. 2010 Oct;163(4):807-16. doi: 10.1111/j.1365-2133.2010.09944.x.
Maybury CM, Porter HF, Kloczko E, Duckworth M, Cotton A, Thornberry K, Dew T, Crook M, Natas S, Miquel R, Lewis CM, Wong T, Smith CH, Barker JN. Prevalence of Advanced Liver Fibrosis in Patients With Severe Psoriasis. JAMA Dermatol. 2019 Sep 1;155(9):1028-1032. doi: 10.1001/jamadermatol.2019.0721.
Other Identifiers
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11/LO/1236
Identifier Type: OTHER
Identifier Source: secondary_id
WS1851782
Identifier Type: -
Identifier Source: org_study_id
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