PsoriasisNCT01604902
miRNAs and mRNAs in Psoriasis
An observational study of Psoriasis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- 4 mm punch biopsies
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients included are adults (> 18 years) with psoriasis vulgaris who are going to be treated with biological drugs independent of this project.
Who may be able to join
- 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.
Who cannot join
- No local treatment 2 weeks before inclusion
- No systemic treatment including UVB 6 weeks before inclusion.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Region Midt, 8000
Lars Iversen, Prof MD PhD, + 45 78611848, lars.iversen@clin.au.dk
Line Raaby, MD, + 45 78461095, line.raaby@clin.au.dk
About this study
Official title: miRNAs and mRNAs in Psoriasis During Treatment With Biological Drugs.
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- 4 mm punch biopsies
- Keywords
- Psoriasis mRNA and miRNA
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mm punch biopsiesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis vulgaris | Patients with psoriasis vulgaris who are going to be treated with biological drugs independent of this project(according to national guidelines). Receives: Other: 4 mm punch biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA and mRNA regulation in psoriatic skin
Measured: jan 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Line R OIsen, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604902
- Sponsor's protocol ID
- 2011-218/2-86
- Status last verified
- Jan 2013
- First submitted
- 22 May 2012
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- miRNAs and mRNAs in Psoriasis During Treatment With Biological Drugs.
- ClinicalTrials.gov ID
- NCT01604902
- Acronym / sponsor ID
- 2011-218/2-86
- Conditions
- Psoriasis
- Keywords
- Psoriasis mRNA and miRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- 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
- Study start
- Mar 2011
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 24 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis vulgaris | – | Other: 4 mm punch biopsiesPatients with psoriasis vulgaris who are going to be treated with biological drugs independent of this project(according to national guidelines). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included are adults (> 18 years) with psoriasis vulgaris who are going to be treated with biological drugs independent of this project.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- No local treatment 2 weeks before inclusion
- No systemic treatment including UVB 6 weeks before inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 mm punch biopsies4 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. | Other | Psoriasis vulgaris |
Primary outcome
miRNA and mRNA regulation in psoriatic skin
Time frame: jan 2015
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Line R OIsen, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Iversen, Prof MD PhD (+45 78461848, lars.iversen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA and mRNA regulation in psoriatic skin (time frame: jan 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2014.