Clinical trial NCT02570750: 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: Chronic Plaque Psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with severe plaque psoriasis and starting an anti-TNF treatment with etanercept

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

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

Primary outcomes:
measure: Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, Week 12, 24
measure: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24
timeFrame: Week 12, 24
measure: Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24
timeFrame: Week 12, 24
measure: Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12
timeFrame: Week 12
measure: Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants
timeFrame: Baseline, Week 12, 24
Other outcomes:
Locations:
city: Pitesti
country: Romania
facility: Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department
state: Arges
city: Pitesti
country: Romania
facility: County Emergency Hospital Pitesti / Dermatology Department
state: Arges
city: Cluj-Napoca
country: Romania
facility: SCBI Ambulatory Cluj-Napoca / Dermatology Department
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Dr. Remus Orasan Medical Office
state: Cluj
city: Targoviste
country: Romania
facility: County Hospital Targoviste / Dermatology Department
state: Dambovita
city: Craiova
country: Romania
facility: Dr Ianosi Medical Center Craiova / Dermatology Department
state: Dolj
city: Craiova
country: Romania
facility: Emergency County Hospital Craiova / Dermatology Department
state: Dolj
city: Craiova
country: Romania
facility: Helios Medica Ambulatory Craiova / Dermatology Department
state: Dolj
city: Baia Mare
country: Romania
facility: Hospital for Infectious Diseases Dermatovenereology and Psychiatry Baia Mare / Dermatology Departmen
state: Maramures
city: Drobeta Turnu Severin
country: Romania
facility: County Emergency Hospital Drobeta Turnu Severin / Dermatology Department
state: Mehedinti
city: Reghin
country: Romania
facility: Derma Luxury Style Medical Office - DR. Serban Diana Ramona Reghin
state: Mures
city: Sighisoara
country: Romania
facility: Sighisoara Municipal Hospital / Dermatology Department
state: Mures
city: Targu Mures
country: Romania
facility: Mures County Clinical Hospital / Dermatology Department
state: Mures
city: Ploiesti
country: Romania
facility: County Emergency Hospital Ploiesti / Dermatology Department
state: Prahova
city: Ploiesti
country: Romania
facility: County Emergency Hospital Ploiesti / Dermatology Department
state: Prahova
city: Zalau
country: Romania
facility: County Emergency Hospital Zalau / Dermatology Department
state: Salaj
city: Timisoara
country: Romania
facility: Municipal Emergency Hospital Timisoara / Dermatology Department
state: Timis
city: Focsani
country: Romania
facility: County Emergency Hospital "Saint Pantelimon" Focsani / Dermatology Department
state: Vrancea
city: Arad
country: Romania
facility: Stoica Dan Marius Dermatology Office Arad
city: Bacau
country: Romania
facility: Emergency Hospital Bacau / Dermatology Department
city: Botosani
country: Romania
facility: County Emergency Hospital "Mavromati" Botosani / Dermatology Department
city: Brasov
country: Romania
facility: County Emergency Hospital Brasov / Dermatology Department
city: Bucharest
country: Romania
facility: Emergency Hospital Militar Central "Dr. Carol Davila" Bucharest / Dermatology Department
city: Bucharest
country: Romania
facility: Elias Emergency University Hospital Bucharest / Dermatology Department
city: Bucharest
country: Romania
facility: Ambulatory Railway Hospital No. 2 Bucharest / Dermatology Department
city: Bucharest
country: Romania
facility: Clinical Hospital Colentina Bucharest / Dermatology Department
city: Bucharest
country: Romania
facility: Hospital "Dr. Victor Babes" Bucharest / Dermatology Department
city: Iasi
country: Romania
facility: County Emergency Hospital "Saint Spiridon" Iasi / Dermatology Department
city: Iasi
country: Romania
facility: Railways Hospital Iasi / Dermatology Department
city: Suceava
country: Romania
facility: Bucovina Medical Office Suceava
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: