miRNAs and mRNAs in Psoriasis
1 other identifier
observational
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 22, 2012
CompletedFirst Posted
Study publicly available on registry
May 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedAugust 25, 2014
January 1, 2013
4 years
May 22, 2012
August 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
miRNA and mRNA regulation in psoriatic skin
jan 2015
Study Arms (1)
Psoriasis vulgaris
Patients with psoriasis vulgaris who are going to be treated with biological drugs independent of this project(according to national guidelines).
Interventions
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.
Eligibility Criteria
Patients included are adults (\> 18 years) with psoriasis vulgaris who are going to be treated with biological drugs independent of this project.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Abbottcollaborator
- Aage Bangs Fondcollaborator
- Aase and Ejnar Danielsens Foundationcollaborator
- Direktør Jacob Madsens Og Hustru Olga Madsens Fondcollaborator
- Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundationcollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, Region Midt, 8000, Denmark
Biospecimen
tissue: 4mm skin pinch biopsies for mRNA and miRNA extration.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Line R OIsen, MD
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2012
First Posted
May 24, 2012
Study Start
March 1, 2011
Primary Completion
March 1, 2015
Study Completion
January 1, 2016
Last Updated
August 25, 2014
Record last verified: 2013-01