Non-interventional Study of the Effect of Smoking Status of the Patient on the Success of Etanercept Therapy in Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192164
• Other study ID #: B1801365
• Status: Completed
• Phase: N/A
• First received: April 11, 2014
• Last updated: September 8, 2016
• Start date: November 2013
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial Summary

Pilot observational study to describe the relationship between the smoking status of a psoriatic individual and the success of etanercept therapy in psoriasis treatment

Description:

non-interventional study There is no sampling

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Exclusion Criteria:

Previous or current treatment with antipsoriatic biologic drugs, such as etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab Chronic or acute infections requiring intravenous or oral anti-infectives within 14 days prior to the Baseline visit

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Behavioral:
• smoking questionnaire
patients fill in a smoking questionnaire about their smoking habits

Locations

Country	Name	City	State
Hungary	Semmelweis University	Budapest
Hungary	Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika	Debrecen
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár
Hungary	Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza	Kecskemet
Hungary	Semmelweis Korhaz-Rendelointezet	Miskolc
Hungary	Pecsi Tudomanyegyetem, Br-, Nemikortani es Onkodermatologiai Klinika	Pecs
Hungary	Medical University of Szeged	Szeged
Hungary	Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly	Szombathely

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Psoriasis Assessment And Severity Index from baseline to 12 weeks and 24 weeks	Commonly used measurement of psoriasis severity by measuring induration, desquamation and erythema of the skin combined with body surface are affected	baseline, 12 weeks, 24 weeks	Yes
Primary	Smoking Habit Questionnaire	Short questionnaire aboout current and past smoking habits of the patients	baseline	No

External Links

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