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

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ClinicalTrials.gov Identifier: NCT02570750
Recruitment Status : Completed
First Posted : October 7, 2015
Results First Posted : December 20, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Chronic Plaque Psoriasis Behavioral: QUESTIONNAIRE ON SMOKING HABITS

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

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Study Type : Observational
Actual Enrollment : 183 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
Actual Study Start Date : May 7, 2015
Actual Primary Completion Date : December 5, 2016
Actual Study Completion Date : December 5, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis Smoking
Drug Information available for: Etanercept

Group/Cohort Intervention/treatment
Group 1: smokers patients group
smokers (more than 10 cigarettes per day)
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.


Group 2 : non-smokers patients group
Smoking status will be classified as current and never/former. Former smokers will be defined as those who had stopped smoking at least 1 year before being interviewed for this study
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.





Primary Outcome Measures :
  1. Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 [ Time Frame: Baseline, 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).


Secondary Outcome Measures :
  1. Change From Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, Week 12, 24 ]
    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.

  2. Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 [ Time Frame: Week 12, 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.

  3. Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24 [ Time Frame: Week 12, 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.

  4. Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 [ Time Frame: 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).

  5. Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants [ Time Frame: Baseline, Week 12, 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). Participants who had bone marrow index >30 kilogram per meter square were said to be obese in this outcome measure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with severe plaque psoriasis and starting an anti-TNF treatment with etanercept
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570750


Locations
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Romania
Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department
Pitesti, Arges, Romania, 110121
County Emergency Hospital Pitesti / Dermatology Department
Pitesti, Arges, Romania, 110283
SCBI Ambulatory Cluj-Napoca / Dermatology Department
Cluj-Napoca, Cluj, Romania, 400001
Dr. Remus Orasan Medical Office
Cluj-Napoca, Cluj, Romania, 400105
County Hospital Targoviste / Dermatology Department
Targoviste, Dambovita, Romania, 130086
Dr Ianosi Medical Center Craiova / Dermatology Department
Craiova, Dolj, Romania, 200061
Emergency County Hospital Craiova / Dermatology Department
Craiova, Dolj, Romania, 200642
Helios Medica Ambulatory Craiova / Dermatology Department
Craiova, Dolj, Romania, 200642
Hospital for Infectious Diseases Dermatovenereology and Psychiatry Baia Mare / Dermatology Departmen
Baia Mare, Maramures, Romania, 430341
County Emergency Hospital Drobeta Turnu Severin / Dermatology Department
Drobeta Turnu Severin, Mehedinti, Romania, 220097
Derma Luxury Style Medical Office - DR. Serban Diana Ramona Reghin
Reghin, Mures, Romania, 545300
Sighisoara Municipal Hospital / Dermatology Department
Sighisoara, Mures, Romania, 545400
Mures County Clinical Hospital / Dermatology Department
Targu Mures, Mures, Romania, 540342
County Emergency Hospital Ploiesti / Dermatology Department
Ploiesti, Prahova, Romania, 100184
County Emergency Hospital Ploiesti / Dermatology Department
Ploiesti, Prahova, Romania, 100576
County Emergency Hospital Zalau / Dermatology Department
Zalau, Salaj, Romania, 450123
Municipal Emergency Hospital Timisoara / Dermatology Department
Timisoara, Timis, Romania, 300077
County Emergency Hospital "Saint Pantelimon" Focsani / Dermatology Department
Focsani, Vrancea, Romania, 620034
Stoica Dan Marius Dermatology Office Arad
Arad, Romania, 310112
Emergency Hospital Bacau / Dermatology Department
Bacau, Romania, 600114
County Emergency Hospital "Mavromati" Botosani / Dermatology Department
Botosani, Romania, 710211
County Emergency Hospital Brasov / Dermatology Department
Brasov, Romania, 500326
Emergency Hospital Militar Central "Dr. Carol Davila" Bucharest / Dermatology Department
Bucharest, Romania, 010825
Elias Emergency University Hospital Bucharest / Dermatology Department
Bucharest, Romania, 011461
Ambulatory Railway Hospital No. 2 Bucharest / Dermatology Department
Bucharest, Romania, 011464
Clinical Hospital Colentina Bucharest / Dermatology Department
Bucharest, Romania, 020125
Hospital "Dr. Victor Babes" Bucharest / Dermatology Department
Bucharest, Romania, 030303
County Emergency Hospital "Saint Spiridon" Iasi / Dermatology Department
Iasi, Romania, 700106
Railways Hospital Iasi / Dermatology Department
Iasi, Romania, 700506
Bucovina Medical Office Suceava
Suceava, Romania, 720019
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02570750     History of Changes
Other Study ID Numbers: B1801392
First Posted: October 7, 2015    Key Record Dates
Results First Posted: December 20, 2018
Last Update Posted: December 20, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors