BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis

Terminated

• Conditions: Psoriasis

• Registration Number: NCT01403012
• Lead Sponsor: Technical University of Munich

Brief Summary

Metabolomics of systemic psoriasis treatment

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Study Start: 2011-08
• Primary Completion: 2014-11-19
• Study Completion: 2015-12-04
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of metabolic profiles associated with treatment response	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

Name	Time	Method
Identification of metabolomic signatures associated with psoriasis	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.

Trial Locations

Locations (1)

Department of Dermatology and Allergy, Uniklinik Kiel; 🇩🇪 Kiel, Schleswig-holstein, Germany