The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
NCT ID: NCT02570750
Last Updated: 2018-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
183 participants
OBSERVATIONAL
2015-05-07
2016-12-05
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Group 1: smokers patients group
smokers (more than 10 cigarettes per day)
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 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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Positive pregnancy test, breast feeding or considering becoming pregnant during the study
* Clinically significant drug or alcohol abuse
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department
Piteşti, Argeş, Romania
County Emergency Hospital Pitesti / Dermatology Department
Piteşti, Argeş, Romania
SCBI Ambulatory Cluj-Napoca / Dermatology Department
Cluj-Napoca, Cluj, Romania
Dr. Remus Orasan Medical Office
Cluj-Napoca, Cluj, Romania
Dr Ianosi Medical Center Craiova / Dermatology Department
Craiova, Dolj, Romania
Emergency County Hospital Craiova / Dermatology Department
Craiova, Dolj, Romania
Helios Medica Ambulatory Craiova / Dermatology Department
Craiova, Dolj, Romania
County Hospital Targoviste / Dermatology Department
Târgovişte, Dâmbovița County, Romania
Hospital for Infectious Diseases Dermatovenereology and Psychiatry Baia Mare / Dermatology Departmen
Baia Mare, Maramureş, Romania
County Emergency Hospital Drobeta Turnu Severin / Dermatology Department
Drobeta-Turnu Severin, Mehedinți County, Romania
Derma Luxury Style Medical Office - DR. Serban Diana Ramona Reghin
Reghin, Mureș County, Romania
Sighisoara Municipal Hospital / Dermatology Department
Sighișoara, Mureș County, Romania
Mures County Clinical Hospital / Dermatology Department
Târgu Mureş, Mureș County, Romania
County Emergency Hospital Ploiesti / Dermatology Department
Ploieşti, Prahova, Romania
County Emergency Hospital Ploiesti / Dermatology Department
Ploieşti, Prahova, Romania
County Emergency Hospital Zalau / Dermatology Department
Zalău, Sălaj County, Romania
Municipal Emergency Hospital Timisoara / Dermatology Department
Timișoara, Timiș County, Romania
County Emergency Hospital "Saint Pantelimon" Focsani / Dermatology Department
Focşani, Vrancea, Romania
Stoica Dan Marius Dermatology Office Arad
Arad, , Romania
Emergency Hospital Bacau / Dermatology Department
Bacau, , Romania
County Emergency Hospital "Mavromati" Botosani / Dermatology Department
Botoșani, , Romania
County Emergency Hospital Brasov / Dermatology Department
Brasov, , Romania
Emergency Hospital Militar Central "Dr. Carol Davila" Bucharest / Dermatology Department
Bucharest, , Romania
Elias Emergency University Hospital Bucharest / Dermatology Department
Bucharest, , Romania
Ambulatory Railway Hospital No. 2 Bucharest / Dermatology Department
Bucharest, , Romania
Clinical Hospital Colentina Bucharest / Dermatology Department
Bucharest, , Romania
Hospital "Dr. Victor Babes" Bucharest / Dermatology Department
Bucharest, , Romania
County Emergency Hospital "Saint Spiridon" Iasi / Dermatology Department
Iași, , Romania
Railways Hospital Iasi / Dermatology Department
Iași, , Romania
Bucovina Medical Office Suceava
Suceava, , Romania
Countries
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Related Links
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Other Identifiers
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B1801392
Identifier Type: -
Identifier Source: org_study_id