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BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis (Bostrip)

This study is currently recruiting participants.
Verified March 2013 by Technische Universität München
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01403012
First received: July 8, 2011
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

Metabolomics of systemic psoriasis treatment


Condition Intervention
Psoriasis
 Other: Withdrawal of venous blood samples

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differential Analysis of Metabolomic Profiles in Patients With Chronic Plaque Psoriasis Undergoing Systemic Treatment

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Analysis of metabolic profiles associated with treatment response
    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.


Secondary Outcome Measures:
  • Identification of metabolomic signatures associated with psoriasis

    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

Psoriasis patients


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Withdrawal of venous blood samples

    Withdrawal of venous blood samples (approx. 20 ml) and 2 skin biopsies (5 mm)

    Laboratory measurements:

    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 and skin biopsies

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Psoriasis patients

Criteria

Inclusion Criteria:

  • Male and female patients aged 18 - 80 years, body weight ≤ 180 kg
  • Dermatological diagnosis of psoriasis
  • Initiated therapy with TNFα-inhibitor agents (etanercept, adalimumab and infliximab)or fumaric acid ester (FAE) within the scope of routine patient care by treating physician
  • Signed informed consent from patient

Exclusion Criteria:

  • Patients with evidence of any skin condition that would interfere with the evaluation of psoriasis
  • Use of systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate, cyclosporine within 30 days of Visit 1 or used FAE or other any biologic agent such as etanercept, infliximab and adalimumab within 12 weeks prior to Visit 1
  • Patients who are considered potentially unreliable or where it is envisaged the patient may not consistently attend scheduled study visits
  • Patients who are unable to complete a patient diary or complete questionnaires on paper
  • Patients with any other condition or prior/current treatment, which in the opinion of the investigator renders the patient ineligible for the study schedule
  • Pregnancy or breast feeding women
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use effective contraception during the study. Effective contraception is defined as either: use of established oral, injected or implanted hormonal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403012

Contacts
Contact: Stephan Weidinger, Prof. Dr. med. ++49-431-597 ext 2623 sweidinger@dermatology.uni-kiel.de

Locations
Germany
Department of Dermatology and Allergy, Uniklinik Kiel Recruiting
Kiel, Schleswig-holstein, Germany, 24105
Contact: Stephan Weidinger, Prof. Dr. med.     ++49-431-597 ext 2623     sweidinger@dermatology.uni-kiel.de    
Principal Investigator: Stephan Weidinger, Prof. Dr. med.            
Sponsors and Collaborators
Technische Universität München
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01403012     History of Changes
Other Study ID Numbers: BOS-1168-WEI-0080-I
Study First Received: July 8, 2011
Last Updated: March 18, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
To identify clinical and metabolomic markers that underlie variability in response to systemic therapy in psoriasis
To identify metabolomic signatures associated with psoriasis
To identify possible treatment-specific metabolomic signatures

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

ClinicalTrials.gov processed this record on May 16, 2013