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

NCT02174367

Last updated date
Study Location
Guys and St Thomas NHS Foundation trust and King's College London
London, , SE1 9RT, United Kingdom
Contact
1-800-718-1021

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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
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

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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
  1. 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.

  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
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
  • Psoriasis Chronic
  • Liver Fibrosis
  • Fatty Liver
  • Non-alcoholic Fatty Liver Disease
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
 (submitted: August 3, 2017)
400
Original Estimated Enrollment
 (submitted: June 24, 2014)
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:

  • 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
Sex/Gender
Sexes Eligible for Study:All
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
Principal Investigator:Jonathan N Barker, BSC MD FRCPKing's College London
Study Director:Catherine H Smith, MD FRCPGuys and St Thomas' Hospitals Foundation Trust and King's College London
PRS Account King's College London
Verification Date June 2017