Status:
TERMINATED
BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis
Lead Sponsor:
Technical University of Munich
Conditions:
Psoriasis
Eligibility:
All Genders
18-80 years
Brief Summary
Metabolomics of systemic psoriasis treatment
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 4 2015
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01403012
Start Date
August 1 2011
End Date
December 4 2015
Last Update
October 15 2019
Active Locations (1)
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1
Department of Dermatology and Allergy, Uniklinik Kiel
Kiel, Schleswig-Holstein, Germany, 24105