BOSTRIP(Investigator Initiated Trial)(Biomarkers of systemic treatment response in Psoriasis)Differential analysis of metabolomic profiles in patients with chronic plaque psoriasis undergoing systemic treatment
- Conditions
- Psoriasis is a chronic hyperproliferative and inflammatory skin disease with its major subtype, chronic plaque-type psoriasis, affecting approximately 2% of individuals in Western populations. It may lead to heavily disfiguring skin involvement, and it is associated with disabling joint disease (psoriatic arthritis, PSA). Psoriasis has a strong genetic component as evidenced by high familial association and twin studies.Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-000815-15-DE
- Lead Sponsor
- Medizinische Fakultät der technischen Universität Muenchen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
•Age 18 -= 80 years, body weight = 180 kg
•Dermatological diagnosis of psoriasis, PASI = 10
•Eligible to receive systemic therapy for psoriasis in accordance with national guidelines (http://www.uni-duesseldorf.de/AWMF/ll/013-001.htm) and summary of product characteristics
•Initiated therapy with TNF?-inhibitor agents (etanercept, adalimumab and infliximab) or fumaric acid ester (FAE) according to national guidelines
•Signed informed consent from patient
•Patients will be permitted to use stable doses of topical corticosteroids during the study if these preparations were of low or moderate potency
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
•Exclusion criteria as given in national guidelines (see enclosure); (http://www.uni-duesseldorf.de/AWMF/ll/013-001.htm) and summary of product characteristics
•Patient with evidence of any skin condition that would interfere with the evaluation of psoriasis;
•Use of FAE or other any biologic agent such as etanercept, infliximab and adalimumab within 4 weeks and 12 weeks prior to Visit 1, respectively
•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 feading women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objectives<br>1.To evaluate the efficacy of TNF?-inhibitor agents, etanercept, adalimumab, infliximab and fumaric acid ester (FAE) in a sample of adult patients with chronic plaque psoriasis<br>;Secondary Objective: Secondary objectives<br>2.To identify clinical and metabolomic markers that underlie variability in response to therapy<br>3.To identify metabolomic signatures associated with psoriasis<br>4.To identify possible treatment-specific metabolomic signatures<br>;Primary end point(s): The primary aim of this study is to evaluate the efficacy of various systemic treatments, i.e. TNF?-inhibitor agents (etanercept, adalimumab, infliximab) and fumaric acid ester (FAE). ;Timepoint(s) of evaluation of this end point: 3 Month
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 3 Month;Secondary end point(s): The secondary aim is to analyse metabolic profiles as well as expression data in patients with chronic plaque psoriasis<br>a) before and during systemic therapy with FAE or TNF-inhibiting agents (etanercept, adalimumab and infliximab) and<br>b) as compared to population-based controls.<br><br>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. Existing data on metabolic profiles and genome-wide (1000k) SNP data from 2000 adults from the population-based KORA studies will be utilised.<br><br>