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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.
Study hypothesis was based on the following rationale:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: smokers patients group | smokers (more than 10 cigarettes per day) |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QUESTIONNAIRE ON SMOKING HABITS | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with severe plaque psoriasis and starting an anti-TNF treatment with etanercept
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bratianu Diagnostic and Treatment Center Pitesti / Dermatology Department | Piteşti | Argeş | 110121 | Romania | ||
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept: Non Smokers | Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per summary of product characteristics (SmPC), were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline, Week 12, 24 |
| 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 |
| 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 |
| 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 |
| 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 |
| County Emergency Hospital Pitesti / Dermatology Department |
| Piteşti |
| Argeş |
| 110283 |
| Romania |
| SCBI Ambulatory Cluj-Napoca / Dermatology Department | Cluj-Napoca | Cluj | 400001 | Romania |
| Dr. Remus Orasan Medical Office | Cluj-Napoca | Cluj | 400105 | Romania |
| Dr Ianosi Medical Center Craiova / Dermatology Department | Craiova | Dolj | 200061 | Romania |
| Emergency County Hospital Craiova / Dermatology Department | Craiova | Dolj | 200642 | Romania |
| Helios Medica Ambulatory Craiova / Dermatology Department | Craiova | Dolj | 200642 | Romania |
| County Hospital Targoviste / Dermatology Department | Targoviste | Dâmbovița County | 130086 | Romania |
| Hospital for Infectious Diseases Dermatovenereology and Psychiatry Baia Mare / Dermatology Departmen | Baia Mare | Maramureş | 430341 | Romania |
| County Emergency Hospital Drobeta Turnu Severin / Dermatology Department | Drobeta-Turnu Severin | Mehedinți County | 220097 | Romania |
| Derma Luxury Style Medical Office - DR. Serban Diana Ramona Reghin | Reghin | Mureș County | 545300 | Romania |
| Sighisoara Municipal Hospital / Dermatology Department | Sighișoara | Mureș County | 545400 | Romania |
| Mures County Clinical Hospital / Dermatology Department | Târgu Mureş | Mureș County | 540342 | Romania |
| County Emergency Hospital Ploiesti / Dermatology Department | Ploieşti | Prahova | 100184 | Romania |
| County Emergency Hospital Ploiesti / Dermatology Department | Ploieşti | Prahova | 100576 | Romania |
| County Emergency Hospital Zalau / Dermatology Department | Zalău | Sălaj County | 450123 | Romania |
| Municipal Emergency Hospital Timisoara / Dermatology Department | Timișoara | Timiș County | 300077 | Romania |
| County Emergency Hospital "Saint Pantelimon" Focsani / Dermatology Department | Focşani | Vrancea | 620034 | Romania |
| Stoica Dan Marius Dermatology Office Arad | Arad | 310112 | Romania |
| Emergency Hospital Bacau / Dermatology Department | Bacau | 600114 | Romania |
| County Emergency Hospital "Mavromati" Botosani / Dermatology Department | Botoșani | 710211 | Romania |
| County Emergency Hospital Brasov / Dermatology Department | Brasov | 500326 | Romania |
| Emergency Hospital Militar Central "Dr. Carol Davila" Bucharest / Dermatology Department | Bucharest | 010825 | Romania |
| Elias Emergency University Hospital Bucharest / Dermatology Department | Bucharest | 011461 | Romania |
| Ambulatory Railway Hospital No. 2 Bucharest / Dermatology Department | Bucharest | 011464 | Romania |
| Clinical Hospital Colentina Bucharest / Dermatology Department | Bucharest | 020125 | Romania |
| Hospital "Dr. Victor Babes" Bucharest / Dermatology Department | Bucharest | 030303 | Romania |
| County Emergency Hospital "Saint Spiridon" Iasi / Dermatology Department | Iași | 700106 | Romania |
| Railways Hospital Iasi / Dermatology Department | Iași | 700506 | Romania |
| Bucovina Medical Office Suceava | Suceava | 720019 | Romania |
| FG001 | Etanercept: Smokers | Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. |
| COMPLETED |
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| NOT COMPLETED |
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Per protocol set included all treated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept: Non Smokers | Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. |
| BG001 | Etanercept: Smokers | Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Per protocol set included all treated participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
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| 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. | Per protocol set included all treated participants. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12, 24 |
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| 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. | Per protocol set included all treated participants. | Posted | Number | percentage of participants | Week 12, 24 |
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| 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. | Per protocol set included all treated participants. | Posted | Number | percentage of participants | Week 12, 24 |
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| 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). | Per protocol set included all treated participants. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| 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. | Per protocol set included all treated participants. Here, "N" (overall number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12, 24 |
|
Baseline up to 1 year
Same event may appear as both an adverse event and serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Adverse events data was planned to be reported for overall population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept: Non Smokers | Non-smoker participants (defined as those who never smoked or quitted smoking at least 1 year prior to the enrollment in study) diagnosed with moderate to severe plaque psoriasis and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. | 0 | 96 | 2 | 96 | 4 | 96 |
| EG001 | Etanercept: Smokers | Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. | 1 | 68 | 3 | 68 | 4 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inflammation at site injection | Infections and infestations | MedDRA v20.0 | Non-systematic Assessment |
| |
| Diabetic gangrene | Endocrine disorders | MedDRA v20.0 | Non-systematic Assessment |
| |
| Cerebellar haematoma | Nervous system disorders | MedDRA v20.0 | Non-systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v20.0 | Non-systematic Assessment |
| |
| Erytrodermic psoriasis | Immune system disorders | MedDRA v20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erytrodermic psoriasis | Skin and subcutaneous tissue disorders | MedDRA v20.0 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA v20.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v20.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v20.0 | Non-systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA v20.0 | Non-systematic Assessment |
| |
| Increase of serum transaminases | Investigations | MedDRA v20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v20.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Male |
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| OG001 |
| Etanercept: Smokers |
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. |
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| OG001 |
| Etanercept: Smokers |
Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. |
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Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. |
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| OG001 | Etanercept: Smokers | Smoker participants (defined as those who smoke more than 10 cigarettes per day), diagnosed with moderate to severe plaque psoriasis, and who were eligible for initiating the etanercept treatment based on physician's discretion as per SmPC, were observed prospectively in this study for 24 weeks. According to SmPC, recommended dose for etanercept is 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly as subcutaneous injection. |
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