Clinical trial NCT02192164: Non-interventional Study of 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis
smoking
etanercept
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: etanercept treated plaque psoriasis patients

Brief 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

Detailed description: non-interventional study There is no sampling

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
timeFrame: Baseline (Day 1), Week 24
Secondary outcomes:
measure: Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
timeFrame: Week 12, 24
measure: Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24
timeFrame: Baseline, Week 12, 24
Other outcomes:
measure: Smoking Habit Questionnaire: Smoking Status of Participants
timeFrame: Day 1
measure: Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted
timeFrame: Day 1
measure: Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants
timeFrame: Day 1
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
city: Miskolc
country: Hungary
facility: Semmelweis Korhaz-Rendelointezet
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem, Br-, Nemikortani es Onkodermatologiai Klinika
city: Szeged
country: Hungary
facility: Medical University of Szeged
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: