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

Last updated on May 10, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
The main purpose of this study is to assess the effect of smoking status on the success of Etanercept therapy in patients with moderate-to-severe psoriasis.

Study hypothesis was based on the following rationale:

  • Psoriasis vulgaris is a chronic inflammatory skin disease with several extracutaneous manifestations and significant comorbidities (among others cardiovascular disease, metabolic syndrome, obesity and depression).
  • An increased prevalence of smoking among psoriasis patients, as compared with healthy subjects, has been observed in several studies
  • More recent studies suggest that cigarette smoking may trigger the development of psoriasis through oxidative, inflammatory and genetic mechanisms.Furthermore, smoking is associated with the clinical severity of psoriasis
  • Smoking also contributes to higher morbidity and mortality from smoking related disorders in these patients There is now some evidence that patients with psoriasis who smoke tend to be less responsive to treatment
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients diagnosed with severe plaque psoriasis and starting an anti-TNF treatment with etanercept
Chronic Plaque Psoriasis
Behavioral: QUESTIONNAIRE ON SMOKING HABITS

Data on smoking will include the age at which cigarette smoking began and ceased and the average amount smoked daily. Intensity (number of cigarettes smoked per day), duration of smoking (years), and time since cessation (years) will be categorized. Also, the smoking status of the patient prior psoriasis diagnosis will be assessed (smoker or non-smoker and years of smoking prior to psoriasis diagnosis).

Smoking habit evaluation: baseline and changes in smoking habit at 12 and 24-weeks follow-up time points.

  • Group 1: smokers patients group
    smokers (more than 10 cigarettes per day)
    Intervention: Behavioral: QUESTIONNAIRE ON SMOKING HABITS
  • Group 2 : non-smokers patients group
    Smoking status will be classified as current and never/former. Former smokers will be defined as those who had stopped smoking at least 1 year before being interviewed for this study
    Intervention: Behavioral: QUESTIONNAIRE ON SMOKING HABITS
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
December 5, 2016
December 5, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
 
NCT02570750
B1801392
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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