BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis (Bostrip)
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|ClinicalTrials.gov Identifier: NCT01403012|
Recruitment Status : Terminated
First Posted : July 27, 2011
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment|
|Psoriasis||Other: Withdrawal of venous blood samples|
|Study Type :||Observational|
|Actual Enrollment :||34 participants|
|Official Title:||Differential Analysis of Metabolomic Profiles in Patients With Chronic Plaque Psoriasis Undergoing Systemic Treatment|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||December 2016|
Other: Withdrawal of venous blood samples
Withdrawal of venous blood samples (approx. 20 ml) and 2 skin biopsies (5 mm)
Fasting serum concentrations of 200 metabolites covering a biologically relevant panel of amino acids, sugars, acylcarnitines and phospholipids Genome-wide expression profiles generated from RNA derived from peripheral leukocytes
- Analysis of metabolic profiles associated with treatment response [ Time Frame: week 0 and week 12 ]The primary aim of this study is to analyze metabolic profiles as well as expression data in patients with chronic plaque psoriasis undergoing systemic treatment with TNF_-inhibitor agents (etanercept, adalimumab, infliximab) and fumaric acid ester (FAE) in order to identify clinical and metabolomic markers that underlie variability in response to therapy.
- Identification of metabolomic signatures associated with psoriasis [ Time Frame: week 0 and week 12 ]
The secondary aim is to identify metabolomic signatures associated with psoriasis and to identify possible treatment-specific metabolomic signatures.
It is anticipated, to get insights into mechanisms of anti-TNF drug action and response as well as first indications for metabotypes that are associated with psoriasis. In addition, genetic variants correlated to these metabotypes might be identified.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403012
|Department of Dermatology and Allergy, Uniklinik Kiel|
|Kiel, Schleswig-holstein, Germany, 24105|
|Principal Investigator:||Stephan Weidinger, Dr. med.||Dermatology, University Kiel|