NCT01403012TerminatedNot Applicable
Differential Analysis of Metabolomic Profiles in Patients With Chronic Plaque Psoriasis Undergoing Systemic Treatment
Technical University of Munich1 site in 1 country34 target enrollmentStarted: August 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Analysis of metabolic profiles associated with treatment response
Study Overview
Brief Summary
Metabolomics of systemic psoriasis treatment
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Analysis of metabolic profiles associated with treatment response
Time Frame: 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 Outcomes
- Identification of metabolomic signatures associated with psoriasis(week 0 and week 12)
Investigators
Study Sites (1)
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