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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01403012
Recruitment Status : Terminated
First Posted : July 27, 2011
Last Update Posted : October 15, 2019
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:
Metabolomics of systemic psoriasis treatment

Condition or disease Intervention/treatment
Psoriasis Other: Withdrawal of venous blood samples

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differential Analysis of Metabolomic Profiles in Patients With Chronic Plaque Psoriasis Undergoing Systemic Treatment
Study Start Date : August 2011
Actual Primary Completion Date : November 19, 2014
Actual Study Completion Date : December 4, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01403012

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

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Responsible Party: Technische Universität München Identifier: NCT01403012     History of Changes
Other Study ID Numbers: BOS-1168-WEI-0080-I
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
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:
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Skin Diseases, Papulosquamous
Skin Diseases