Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT02570750
Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged ≥18 years at the time of screening
* Clinical diagnosis of chronic plaque type psoriasis for at least 6 months as determined by the subjects medical history, and confirmation of the diagnosis through physical examination by the investigator
* Patients who are scheduled by their dermatologist to initiate treatment with Etanercept prescribed independently by the investigator as per local clinical practice guideline
* Stable plaque psoriasis for at least 2 months prior to Baseline
* Diagnosis of severe psoriasis defined as PASI \> 10
* Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC)
* Smokers with smoking \>10 cigarettes daily for smokers group (Group 1) or non-smokers for non-smoking group (Group 2)
* Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study
Exclusion Criteria:
* Previous or current treatment with antipsoriatic biologic drugs, such as Etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab.
* Exclusion Criteria according to the Enbrel® SmPC, with particular attention to: hypersensitivity to the active substance (etanercept) or to any of the excipients; sepsis or risk of sepsis, active infections, including chronic or localised infections.
* Positive pregnancy test, breast feeding or considering becoming pregnant during the study
* Clinically significant drug or alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02570750
Study Brief:
Protocol Section:
NCT02570750