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The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis

Last updated on March 14, 2019

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Study Location
Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department
Pitesti, Arges, 110121 Romania
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Plaque Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT02570750
Pfizer
Completed
The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis

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