An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis

Non-alcoholic Fatty Liver Disease Clinical Trial

— CORE  

Official title:

An Observational Cohort Study to Evaluate Factors Affecting Prevalence of Fatty Liver Disease and Fibrosis and Factors Affecting Response to Treatment in Patients With Psoriasis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02174367
• Other study ID #: WS1851782
• Secondary ID: 11/LO/1236
• Status: Active, not recruiting
• Phase: N/A
• First received: May 22, 2014
• Last updated: August 3, 2017
• Start date: November 2012
• Est. completion date: July 2021

Study information

• Verified date: June 2017
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• Main objectives and outcome measures.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: July 2021
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients who have given written informed consent

• Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past.

• 18 yrs. of age

Exclusion Criteria:

• Patients who have not given written informed consent

• Patients under 18 yrs. of age

• Patients with a PASI less than 10.

• Pregnant women

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis
• Non-alcoholic Fatty Liver Disease
• Psoriasis
• Psoriasis Chronic

Intervention

Device:
• Transient elastography
a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas NHS Foundation trust and King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Pfizer

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

Boehncke WH, Boehncke S, Schön MP. Managing comorbid disease in patients with psoriasis. BMJ. 2010 Jan 15;340:b5666. doi: 10.1136/bmj.b5666. Review. — View Citation

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. Erratum in: Br J Dermatol. 2012 Jun;166(6):1381. Br J Dermatol. 2014 Jan;170(1):226. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. Review. — View Citation

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. — View Citation

Smith CH, Barker JN. Psoriasis and its management. BMJ. 2006 Aug 19;333(7564):380-4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sensitivity, specificity, and likelihood ratios of noninvasive tests of liver fibrosis	The performance of non-invasive markers of fibrosis including standard liver function tests, P3NP, transient elastography and abdominal ultrasound will be assessed in this cohort of patients with chronic plaque psoriasis.	Within 12 months of enrollment
Other	Response to treatment measured by PASI and PGA scores	Response to treatment will be measure by physician global assessment (PGA) PASI and DLQI. Factors assessed include demographic data, psoriasis disease history, co-morbid disease and family history assessed by questionnaire. Lipid and glycaemic status assessed by fasting bloods.	12-24 months following enrollment
Primary	Number of participants with liver fibrosis.	Liver fibrosis will be assessed by transient elastography and the use of standard liver function tests and other serum markers of fibrosis including P3NP. In a minority of cases fibrosis will be diagnosed by liver biopsy and evaluation of histology. Risk factors for the development of fibrosis including metabolic syndrome, alcohol and methotrexate use will be evaluated.	12 months after enrollment
Secondary	Number of participants with fatty liver disease diagnosed by ultrasound	Fatty liver disease will be defined by the presence or absence of fatty changes on abdominal ultrasound. Risk factors for the development of fatty liver disease including abdominal obesity, diabetes, and alcohol use will be evaluated.	Within 12 months of enrollment