miRNAs and mRNAs in Psoriasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Aarhus
Sponsor:
Collaborators:
Abbott
Aage Bangs Fond
Aase and Ejnar Danielsens Foundation
Direktør Jacob Madsens Og Hustru Olga Madsens Fond
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01604902
First received: May 22, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

PURPOSE - The purpose of this study is to identify and determine miRNA expression and their targets before and during biological treatment of psoriatic patients.

HYPOTHESIS - Changes in the expression of specific miRNAs play an important role for the cytokine expression profile seen in lesional psoriatic skin. miRNAs may therefore serve as a potential target for future anti-psoriatic treatment as well as possible predictors of biological treatment response.

PERSPECTIVES - The results from this novel research project will increase the investigators understanding of the underlying mechanisms leading to psoriasis. Furthermore it is possible that predictors of treatment response can be identified. Identification of biomarkers predicting treatment outcome will individualize patient care, reduce number of treatment failures and thereby have a tremendous socio-economic impact and increase the patients quality of life.


Condition Intervention
Psoriasis
Other: 4 mm punch biopsies

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: miRNAs and mRNAs in Psoriasis During Treatment With Biological Drugs.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • miRNA and mRNA regulation in psoriatic skin [ Time Frame: jan 2015 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

tissue: 4mm skin pinch biopsies for mRNA and miRNA extration.


Estimated Enrollment: 10
Study Start Date: March 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Psoriasis vulgaris
Patients with psoriasis vulgaris who are going to be treated with biological drugs independent of this project(according to national guidelines).
Other: 4 mm punch biopsies
4 mm punch-biopsies from lesional and non-lesional psoriatic skin at day 0 and up to four times after treatment at the following days: 4, 14, 28 or 84.

Detailed Description:

BACKGROUND: Psoriasis is a chronic inflammatory skin disease affecting 2-3% of the population worldwide and having tremendously impact on the patients' quality of life. Progress has been made in the understanding of the cellular immunology and biology of psoriasis, but the ultimate cause for psoriasis is still unknown.

miRNA are ~22 nt noncoding RNAs that modulate gene expression at the post-transcriptional level. miRNAs have regulatory roles in development, differentiation, growth control and apoptosis.

AIM OF PROJECT: To identify psoriasis specific miRNA. To investigate the differences in miRNA expression and their targets between lesional and non-lesional psoriatic skin. To investigate changes in the miRNA expression during biological treatment.

METHODS: Patients included are adults (> 18 years) with psoriasis vulgaris who are going to be treated with biological drugs independent of this project (according to national guidelines). A signed informed consent will be obtained before patients are included in the project.

Patients are not allowed to have received local treatment 2 weeks before inclusion or having had any systemic treatment including UVB 6 weeks before inclusion. 4 mm punch-biopsies from lesional and non-lesional psoriatic skin will be obtained using a local anaesthetic containing 1% Lidocaine at day 0 and up to four times after treatment at the following days 4, 14, 28 or 84. Before and during treatment patients will be monitored with a clinical score including PASI, BSA and PGA. Clinical evaluation will be conducted by a trained dermatologist at day 0 and day 84. That allows us to compare clinical changes to findings obtained during this study.

miRNA and mRNA expression will be analysis with quantitativePCR, protein level with ELISA and cell proliferation will be measure by a standard cell proliferation assay. miRNA microarray are commercially available and will be used to identify miRNA of interest.

NOVELTY: Changes in the expression of miRNA in psoriasis and miRNA regulation during treatment of psoriasis have only been sparsely studied. The results from this research project will therefore increase our understanding of the underlying mechanisms leading to psoriasis and may generate important new tools for individualised treatment of psoriasis.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients included are adults (> 18 years) with psoriasis vulgaris who are going to be treated with biological drugs independent of this project.

Criteria

Inclusion Criteria:

  • Males and females aged 18 or above
  • Patients with psoriasis vulgaris who are going to be treated with biological drugs independent of this project.
  • A signed informed consent form prior of any study-mandated procedure.

Exclusion Criteria:

  • No local treatment 2 weeks before inclusion
  • No systemic treatment including UVB 6 weeks before inclusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604902

Contacts
Contact: Lars Iversen, Prof MD PhD +45 78461848 lars.iversen@ki.au.dk
Contact: Line R Olsen, MD + 45 78461905 line.raaby.olsen@ki.au.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Region Midt, Denmark, 8000
Contact: Lars Iversen, Prof MD PhD    + 45 78611848    lars.iversen@ki.au.dk   
Contact: Line R Olsen, MD    + 45 78461095    line.raaby.olsen@ki.au.dk   
Principal Investigator: Lars Iversen, Prof MD PhD         
Sponsors and Collaborators
University of Aarhus
Abbott
Aage Bangs Fond
Aase and Ejnar Danielsens Foundation
Direktør Jacob Madsens Og Hustru Olga Madsens Fond
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Investigators
Principal Investigator: Line R OIsen, MD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01604902     History of Changes
Other Study ID Numbers: 2011-218/2-86
Study First Received: May 22, 2012
Last Updated: January 15, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Psoriasis mRNA and miRNA

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 01, 2014