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BOSTRIP: Biomarkers of Systemic Treatment Response in Psoriasis (Bostrip)

T

Technical University of Munich

Status

Terminated

Conditions

Psoriasis

Treatments

Other: Withdrawal of venous blood samples

Study type

Observational

Funder types

Other

Identifiers

NCT01403012
BOS-1168-WEI-0080-I

Details and patient eligibility

About

Metabolomics of systemic psoriasis treatment

Enrollment

34 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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