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| ID | Type | Description | Link |
|---|---|---|---|
| 11/LO/1236 | Other Identifier | London REC reference number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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• Main objectives and outcome measures.
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).
Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transient elastography | Device | a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Hospital outpatient clinic
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys and St Thomas NHS Foundation trust and King's College London | London | SE1 9RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24606161 | Background | 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. | |
| 24588075 | 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. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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Serum stored for analysis of non-invasive markers of fibrosis and DNA analysis
| 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 |
| 24715130 | 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. |
| 16916825 | 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. |
| 19641206 | 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. |
| 20080817 | 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. |
| 20662837 | 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. |
| 31166567 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |