The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis

Chronic 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: NCT02570750
• Other study ID #: B1801392
• Status: Completed
• Start date: May 7, 2015
• Est. completion date: December 5, 2016

Study information

• Verified date: June 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: December 5, 2016
• Est. primary completion date: December 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Plaque Psoriasis
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
Romania	Stoica Dan Marius Dermatology Office Arad	Arad
Romania	Emergency Hospital Bacau / Dermatology Department	Bacau
Romania	Hospital for Infectious Diseases Dermatovenereology and Psychiatry Baia Mare / Dermatology Departmen	Baia Mare	Maramures
Romania	County Emergency Hospital "Mavromati" Botosani / Dermatology Department	Botosani
Romania	County Emergency Hospital Brasov / Dermatology Department	Brasov
Romania	Ambulatory Railway Hospital No. 2 Bucharest / Dermatology Department	Bucharest
Romania	Clinical Hospital Colentina Bucharest / Dermatology Department	Bucharest
Romania	Elias Emergency University Hospital Bucharest / Dermatology Department	Bucharest
Romania	Emergency Hospital Militar Central "Dr. Carol Davila" Bucharest / Dermatology Department	Bucharest
Romania	Hospital "Dr. Victor Babes" Bucharest / Dermatology Department	Bucharest
Romania	Dr. Remus Orasan Medical Office	Cluj-Napoca	Cluj
Romania	SCBI Ambulatory Cluj-Napoca / Dermatology Department	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 Emergency Hospital Drobeta Turnu Severin / Dermatology Department	Drobeta Turnu Severin	Mehedinti
Romania	County Emergency Hospital "Saint Pantelimon" Focsani / Dermatology Department	Focsani	Vrancea
Romania	County Emergency Hospital "Saint Spiridon" Iasi / Dermatology Department	Iasi
Romania	Railways Hospital Iasi / Dermatology Department	Iasi
Romania	Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department	Pitesti	Arges
Romania	County Emergency Hospital Pitesti / Dermatology Department	Pitesti	Arges
Romania	County Emergency Hospital Ploiesti / Dermatology Department	Ploiesti	Prahova
Romania	County Emergency Hospital Ploiesti / Dermatology Department	Ploiesti	Prahova
Romania	Derma Luxury Style Medical Office - DR. Serban Diana Ramona Reghin	Reghin	Mures
Romania	Sighisoara Municipal Hospital / Dermatology Department	Sighisoara	Mures
Romania	Bucovina Medical Office Suceava	Suceava
Romania	County Hospital Targoviste / Dermatology Department	Targoviste	Dambovita
Romania	Mures County Clinical Hospital / Dermatology Department	Targu Mures	Mures
Romania	Municipal Emergency Hospital Timisoara / Dermatology Department	Timisoara	Timis
Romania	County Emergency Hospital Zalau / Dermatology Department	Zalau	Salaj

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24	PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).	Baseline, Week 24
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI)	The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.	Baseline, Week 12, 24
Secondary	Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24	PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline.	Week 12, 24
Secondary	Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24	PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI50 response was defined as at least a 50% reduction in PASI relative to baseline.	Week 12, 24
Secondary	Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12	PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).	Week 12
Secondary	Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants	PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). Participants who had bone marrow index >30 kilogram per meter square were said to be obese in this outcome measure.	Baseline, Week 12, 24

External Links

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