Psoriasis
Conditions
Keywords
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
Brief summary
Metabolomics of systemic psoriasis treatment
Interventions
OTHERWithdrawal 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
Sponsors
Technical University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed