BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis

Psoriasis Clinical Trial

— Bostrip  

Official title:

Differential Analysis of Metabolomic Profiles in Patients With Chronic Plaque Psoriasis Undergoing Systemic Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01403012
• Other study ID #: BOS-1168-WEI-0080-I
• Status: Terminated
• Start date: August 2011
• Est. completion date: December 4, 2015

Study information

• Verified date: October 2019
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Metabolomics of systemic psoriasis treatment

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: December 4, 2015
• Est. primary completion date: November 19, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male and female patients aged 18 - 80 years, body weight = 180 kg

• Dermatological diagnosis of psoriasis

• Initiated therapy with TNFa-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

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Dermatology and Allergy, Uniklinik Kiel	Kiel	Schleswig-holstein

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 0 and week 12
Secondary	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.	week 0 and week 12