An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis
NCT02174367
Last updated date
ABOUT THIS STUDY
• 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
Study Location
Guys and St Thomas NHS Foundation trust and King's College London
London, , SE1 9RT, United Kingdom
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis Chronic, Liver Fibrosis, Fatty Liver, Non-alcoholic Fatty Liver Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-100 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients who have not given written informed consent
- Patients under 18 yrs. of age
- Patients with a PASI less than 10.
- Pregnant women
NEED INFO?
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Psoriasis Chronic, Liver Fibrosis, Fatty Liver, Non-alcoholic Fatty Liver DiseaseAn Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis
NCT02174367
- London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | An Observational Cohort Study Evaluating Fatty Liver Disease and Liver Fibrosis in Moderate to Severe Psoriasis | ||||||
| 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 | ||||||
| Brief Summary | ? Main objectives and outcome measures.
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).
| ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Retention: Samples With DNA Description: Serum stored for analysis of non-invasive markers of fibrosis and DNA analysis | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | Hospital outpatient clinic | ||||||
| Condition |
| ||||||
| Intervention | Device: Transient elastography
a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis Other Name: Fibroscan | ||||||
| Study Groups/Cohorts | 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. Intervention: Device: Transient elastography | ||||||
| Publications * |
| ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status | Active, not recruiting | ||||||
| Actual Enrollment | 400 | ||||||
| Original Estimated Enrollment | 380 | ||||||
| Estimated Study Completion Date | July 2021 | ||||||
| Actual Primary Completion Date | July 2017 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender |
| ||||||
| Ages | 18 Years to 100 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United Kingdom | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT02174367 | ||||||
| Other Study ID Numbers | WS1851782 11/LO/1236 ( Other Identifier: London REC reference number ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | King's College London | ||||||
| Study Sponsor | King's College London | ||||||
| Collaborators | Pfizer | ||||||
| Investigators |
| ||||||
| PRS Account | King's College London | ||||||
| Verification Date | June 2017 | ||||||