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

This study has been terminated.
Information provided by (Responsible Party):
Technische Universität München Identifier:
First received: July 8, 2011
Last updated: March 16, 2016
Last verified: March 2016
Metabolomics of systemic psoriasis treatment

Condition Intervention
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:

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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
Psoriasis patients

Enrollment: 34
Study Start Date: August 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Psoriasis patients

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
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Please refer to this study by its identifier: NCT01403012

Department of Dermatology and Allergy, Uniklinik Kiel
Kiel, Schleswig-holstein, Germany, 24105
Sponsors and Collaborators
Technische Universität München
Principal Investigator: Stephan Weidinger, Dr. med. Dermatology, University Kiel
  More Information

Responsible Party: Technische Universität München Identifier: NCT01403012     History of Changes
Other Study ID Numbers: BOS-1168-WEI-0080-I
Study First Received: July 8, 2011
Last Updated: March 16, 2016

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:
Skin Diseases, Papulosquamous
Skin Diseases processed this record on May 22, 2017