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

NCT02174367 | Unknown DMC

• 2 other identifiers: WS185178211/LO/1236
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Psoriasis Chronic; Liver Fibrosis; Fatty Liver; Non-alcoholic Fatty Liver Disease

Keywords

Chronic plaque psoriasis; Liver fibrosis; Fatty liver disease; Non-alcoholic fatty liver disease; Transient elastography; Fibroscan; Procollagen-3 N-Terminal peptide; Alanine aminotransferase; Liver function tests

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with fatty liver disease diagnosed by ultrasound

  Within 12 months of enrollment

Other Outcomes (2)

• Sensitivity, specificity, and likelihood ratios of noninvasive tests of liver fibrosis

  Within 12 months of enrollment

• Response to treatment measured by PASI and PGA scores

  12-24 months following enrollment

Study Arms (1)

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.

Device: Transient elastography

Interventions

Transient elastography DEVICE

a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis

Also known as: Fibroscan

Psoriasis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospital outpatient clinic

You may qualify if:

• Patients who have given written informed consent
• Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past.
• yrs. of age

You may not qualify if:

• Patients who have not given written informed consent
• Patients under 18 yrs. of age
• Patients with a PASI less than 10.
• Pregnant women

Sponsors & Collaborators

• King's College London: lead
• Pfizer: collaborator

Study Sites (1)

Guys and St Thomas NHS Foundation trust and King's College London

London, SE1 9RT, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 24606161 BACKGROUND

• 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.

  PMID: 24588075 BACKGROUND

• 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.

  PMID: 24715130 BACKGROUND

• 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.

  PMID: 16916825 BACKGROUND

• 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.

  PMID: 19641206 BACKGROUND

• 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.

  PMID: 20080817 BACKGROUND

• 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.

  PMID: 20662837 BACKGROUND

• 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.

  PMID: 31166567 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum stored for analysis of non-invasive markers of fibrosis and DNA analysis

MeSH Terms

Conditions

Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan N Barker, BSC MD FRCP

  King's College London

  PRINCIPAL INVESTIGATOR

• Catherine H Smith, MD FRCP

  Guys and St Thomas' Hospitals Foundation Trust and King's College London

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 25, 2014
• Study Start: November 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2021
• Last Updated: August 4, 2017

Record last verified: 2017-06

Locations

GB (1)