BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis

NCT ID: NCT01403012

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-12-04

Brief Summary

Metabolomics of systemic psoriasis treatment

Conditions

Psoriasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephan Weidinger, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Dermatology, University Kiel

Locations

Department of Dermatology and Allergy, Uniklinik Kiel

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

BOS-1168-WEI-0080-I

Identifier Type: -

Identifier Source: org_study_id