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Pilot observational study to describe the relationship between the smoking status of a psoriatic individual and the success of etanercept therapy in psoriasis treatment
non-interventional study There is no sampling
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smoking questionnaire | Behavioral | patients fill in a smoking questionnaire about their smoking habits |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24 | PASI score 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: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. | Baseline (Day 1), Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 | PASI score 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: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Habit Questionnaire: Smoking Status of Participants | Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking status of participants. Smoking status of participants was classified as never smoked, current smokers, and former smokers. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study. | Day 1 |
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
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etanercept treated plaque psoriasis patients
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University | Budapest | H-1085 | Hungary | |||
| Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika |
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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 | Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician's discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated participants with available post-baseline documentation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants who had moderate to severe plaque psoriasis and commenced treatment based on treating physician's discretion as per Summary of Product Characteristics (SmPC) were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 score 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: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. | All treated participants with available post-baseline documentation. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1), Week 24 |
|
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Due to non-interventional nature of the study, safety data was not planned to be collected.
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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 | Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. |
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Prioritization of outcome measures as primary and secondary was based on the study team's discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Baseline, Week 12 |
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | PASI score 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: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. | Week 12, 24 |
| Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24 | Percentage improvement in PASI score from baseline was calculated at Week 12 and 24 in terms of percent change from baseline. PASI score 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: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. | Baseline, Week 12, 24 |
| Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted | Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking which included the age of participants at which they started smoking and the age at which they quitted smoking. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study. | Day 1 |
| Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants | Smoking habit questionnaire which was conducted on Day 1, assessed the data on smoking which included the mean duration (in years) of smoking among participants. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study. | Day 1 |
| Debrecen |
| 4032 |
| Hungary |
| Somogy Megyei Kaposi Mór Oktató Kórház | Kaposvár | H-7400 | Hungary |
| Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza | Kecskemét | 6000 | Hungary |
| Semmelweis Korhaz-Rendelointezet | Miskolc | 3529 | Hungary |
| Pecsi Tudomanyegyetem, Br-, Nemikortani es Onkodermatologiai Klinika | Pécs | H-7624 | Hungary |
| Medical University of Szeged | Szeged | 6720 | Hungary |
| Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly | Szombathely | 9700 | Hungary |
| Did not meet the exclusion criteria |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Etanercept: Non Smokers |
Participants who had never smoked and those who had quitted smoking at least 1 year prior to the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. |
| OG001 | Etanercept: Smokers | Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. |
|
|
|
| Secondary | Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12 | PASI score 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: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. | All treated participants with available post-baseline documentation. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
|
|
|
| Secondary | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24 | PASI score 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: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. | All treated participants with available post-baseline documentation. | Posted | Number | percentage of participants | Week 12, 24 |
|
|
|
| Secondary | Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24 | Percentage improvement in PASI score from baseline was calculated at Week 12 and 24 in terms of percent change from baseline. PASI score 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: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. | All treated participants with available post-baseline documentation. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 12, 24 |
|
|
|
| Other Pre-specified | Smoking Habit Questionnaire: Smoking Status of Participants | Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking status of participants. Smoking status of participants was classified as never smoked, current smokers, and former smokers. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study. | All treated participants with available post-baseline documentation. | Posted | Number | participants | Day 1 |
|
|
|
| Other Pre-specified | Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted | Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking which included the age of participants at which they started smoking and the age at which they quitted smoking. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study. | All treated participants with available post-baseline documentation. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for each arm. Data for this outcome measure was planned to be analyzed in smokers and former smokers. | Posted | Mean | Standard Error | years | Day 1 |
|
|
|
| Other Pre-specified | Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants | Smoking habit questionnaire which was conducted on Day 1, assessed the data on smoking which included the mean duration (in years) of smoking among participants. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study. | All treated participants with available post-baseline documentation. Here, 'N' signifies those participants who were evaluable for this measure. Data for this outcome measure was planned to be analyzed in smokers and former smokers. | Posted | Mean | Standard Error | years | Day 1 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Etanercept: Smokers | Participants who were smokers during the study and had moderate to severe plaque psoriasis, commenced treatment based on treating physician's discretion as per SmPC were observed prospectively for 24 weeks. According to SmPC, recommended dose included etanercept 25 mg twice weekly, 50 mg once weekly or 50 mg twice weekly subcutaneous injection. | 0 | 0 | 0 | 0 |
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.
| Former smokers |
|