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

NCT02570750

Last updated date
Study Location
Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department
Pitesti, Arges, 110121, Romania
Contact
1-800-718-1021

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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

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Chronic Plaque PsoriasisThe Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
NCT02570750
  1. Pitesti, Arges
  2. Pitesti, Arges
  3. Cluj-Napoca, Cluj
  4. Cluj-Napoca, Cluj
  5. Targoviste, Dambovita
  6. Craiova, Dolj
  7. Craiova, Dolj
  8. Craiova, Dolj
  9. Baia Mare, Maramures
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  20. Bacau,
  21. Botosani,
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  23. Bucharest,
  24. Bucharest,
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  26. Bucharest,
  27. Bucharest,
  28. Iasi,
  29. Iasi,
  30. Suceava,
ALL GENDERS
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Advanced Information
Descriptive Information
Brief Title The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Official Title Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Brief Summary 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.
Detailed Description

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
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with severe plaque psoriasis and starting an anti-TNF treatment with etanercept
Condition Chronic Plaque Psoriasis
Intervention 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.

Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 1, 2017)
183
Original Estimated Enrollment
 (submitted: October 5, 2015)
190
Actual Study Completion Date December 5, 2016
Actual Primary Completion Date December 5, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Romania
Removed Location Countries  
 
Administrative Information
NCT Number NCT02570750
Other Study ID Numbers B1801392
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2018