BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis

NCT01403012 | Terminated

• 1 other identifier: BOS-1168-WEI-0080-I
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Metabolomics of systemic psoriasis treatment

Conditions

Psoriasis

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

Outcome Measures

Primary Outcomes (1)

• Analysis of metabolic profiles associated with treatment response

  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.

  week 0 and week 12

Secondary Outcomes (1)

• Identification of metabolomic signatures associated with psoriasis

  week 0 and week 12

Interventions

Withdrawal of venous blood samples OTHER

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Psoriasis patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Dermatology and Allergy, Uniklinik Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Psoriasis patients

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Stephan Weidinger, Dr. med.

  Dermatology, University Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 27, 2011
• Study Start: August 1, 2011
• Primary Completion: November 19, 2014
• Study Completion: December 4, 2015
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

DE (1)