NCT02570750

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Plaque Psoriasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-05-07
• Primary completion: 2016-12-05
• Completion: 2016-12-05
• First posted: 2015-10-07
• Last updated: 2018-12-20
• Results posted: 2018-12-20

Locations

30 sites across 1 country: Romania