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In recent years, biologics have changed the treatment of psoriasis, giving us additional therapeutic options that are potentially less toxic to the liver, kidneys, and bone marrow and are not teratogenic. Nevertheless, traditional systemic therapies continue to play an important role in the treatment of psoriasis in Turkey, even in patients who are requiring biologic treatments according to national recommendations. This study is designated to observe the effectiveness and safety of tumor necrosis factor inhibitors in patients with moderate to severe psoriasis.
Patients admitted to dermatology clinics, with moderate to severe psoriasis for whom the physician has decided to initiate psoriasis treatment with anti-TNFs in accordance with Turkish Ministry of Health regulations and reimbursements. (Tumor necrosis factor inhibitors can be used for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A. Patients should be screened for latent tuberculosis and appropriate anti-tuberculosis prophylaxis must be initiated if latent tuberculosis is diagnosed). This is a national, multi-center, observational, prospective photographic atlas study in patients who are treated with tumor necrosis factor inhibitors for moderate to severe psoriasis in daily clinic according to Turkish regulations and reimbursement. Demographic data will be collected by the investigator at the beginning of the study. Every participant will be examined by the investigator and the Psoriasis Area Severity Index will be determined at the beginning of the study and at weeks 4, 8, 16 and 24. Each patient will be asked to fill out the Dermatology Life Quality Index at each visit. Each patient will be asked to fill out the Work Productivity and Activity Impairment Questionnaire: Psoriasis at the beginning and last visit (week 24). A standardized set of photographs will be taken at the beginning of the study and at weeks 4, 8, 16 and 24 by a dermatologist trained about standardized photograph positioning and settings. Psoriasis Area Severity Index, Dermatology Life Quality Index and Photographic scores will be statistically analyzed separately in order to evaluate treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-TNF | Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100. | Baseline and Weeks 4, 8, 16 and 24 |
| Percentage of Participants With 75% Reduction in PASI Score | The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome). | Baseline and Weeks 4, 8, 16 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Physician Global Assessment (PGA) of Change in Psoriasis | In the dynamic physician global assessment of change in psoriasis, the physician compared sets of standardized photographs taken at Baseline and at Week 24 for each participant and rated the change of psoriasis severity on the dynamic PGA scale from -5 (considerable deterioration), 0 (no or minimal change) to +5 (considerable improvement). |
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Inclusion Criteria:
Exclusion Criteria:
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University hospitals in Turkey
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| Name | Affiliation | Role |
|---|---|---|
| Mahmut Gucuk, MD | Abbott Laboratories Ithalat, Ithalat ve Tic. Ltd. Sti | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 38780 | Afyonkarahisar | 03000 | Turkey (Türkiye) | |||
| Site Reference ID/Investigator# 27422 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anti-TNF | Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline and Week 24 |
| Dynamic Patient Global Assessment (PGA) of Change in Psoriasis | In the dynamic patient global assessment of change in psoriasis, the participant compared their own sets of standardized photographs taken at Baseline and at Week 24 and rated the change of the severity of psoriasis using the dynamic photographic scale adapted to a visual analog scale ranging from -5 (very large deterioration) to +5 (very large improvement). | Baseline and Week 24 |
| Static Physician Global Assessment (PGA) of Psoriasis | In the static physician assessment of psoriasis, psoriasis severity was rated first for all Baseline photographs and then for all Week 24 photographs according to the following scale: Clear (no lesion); Psoriasis almost cleared; Mild psoriasis; Mild to moderate psoriasis; Moderate psoriasis; Moderate to severe psoriasis; Severe psoriasis. | Baseline and Week 24 |
| Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100. | Baseline and Weeks 4, 8, 16 and 24 |
| Percent Change From Baseline in Work Productivity and Activity Impairment | The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):
Each domain score ranges from 0 (no impairment) to 100 (complete impairment). Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100. | Baseline and Week 24 |
| Number of Participants With Adverse Events (AEs) | The number of participants experiencing any adverse event or a serious adverse event during the study are summarized. A serious AE is an event that results in death, is life-threatening, requires or prolongs hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity or is an important medical event that may require medical or surgical intervention to prevent any of the outcomes listed above. Please see the Adverse Event module below for additional details. | 24 Weeks |
| Ankara |
| 06000 |
| Turkey (Türkiye) |
| Site Reference ID/Investigator# 38776 | Ankara | 06000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38777 | Ankara | 06000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38763 | Ankara | 06100 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38767 | Aydin | 09000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38769 | Bursa | 16000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38779 | Edirne | 22030 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38782 | Gaziantep | 27000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38778 | Hatay | 31000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38786 | Isparta | 32000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38765 | Istanbul | 34000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38771 | Istanbul | 34093 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38766 | Istanbul | 34390 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38770 | Istanbul | 34668 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38764 | Izmir | 35000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 44102 | Kirikkale | 71100 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 44104 | Kocaeli | 41380 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38781 | Konya | 42000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38773 | Malatya | 44000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38768 | Manisa | 45000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 38772 | Mersin | 33000 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 44262 | Samsun | 55139 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 44103 | Sivas | 58140 | Turkey (Türkiye) |
| Site Reference ID/Investigator# 44105 | Zonguldak | 67600 | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-TNF | Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Data available for 102 participants. | Mean | Standard Deviation | years |
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| Gender | Data available for 102 participants. | Number | participants |
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| Region of Enrollment | Number | participants |
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| Weight | Data available for 102 participants. | Mean | Standard Deviation | kg |
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| Height | Data available for 101 participants. | Mean | Standard Deviation | cm |
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| Body Mass Index (BMI) | Data available for 101 participants. | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||||||
| Psoriasis Area and Severity Index (PASI) Score | Psoriasis Area and Severity Index (PASI) score is based on assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome). | Mean | Standard Deviation | scores on a scale |
| |||||||||||||||||||||
| Dermatology Life Quality Index (DLQI) Score | DLQI is a questionnaire to evaluate dermatology patients for their quality of life for the following subsets of parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Questions related with these parameters are summed up and the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on patient's life whereas 0-1 means that the disease has no effect at all. | Mean | Standard Deviation | scores on a scale |
| |||||||||||||||||||||
| Duration of Psoriasis | Data available for 102 participants. | Mean | Standard Deviation | years |
|
| 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 | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100. | Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. | Posted | Mean | Standard Deviation | Percent change | Baseline and Weeks 4, 8, 16 and 24 |
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| Secondary | Dynamic Physician Global Assessment (PGA) of Change in Psoriasis | In the dynamic physician global assessment of change in psoriasis, the physician compared sets of standardized photographs taken at Baseline and at Week 24 for each participant and rated the change of psoriasis severity on the dynamic PGA scale from -5 (considerable deterioration), 0 (no or minimal change) to +5 (considerable improvement). | Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 24 |
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| Secondary | Dynamic Patient Global Assessment (PGA) of Change in Psoriasis | In the dynamic patient global assessment of change in psoriasis, the participant compared their own sets of standardized photographs taken at Baseline and at Week 24 and rated the change of the severity of psoriasis using the dynamic photographic scale adapted to a visual analog scale ranging from -5 (very large deterioration) to +5 (very large improvement). | Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 24 |
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| Secondary | Static Physician Global Assessment (PGA) of Psoriasis | In the static physician assessment of psoriasis, psoriasis severity was rated first for all Baseline photographs and then for all Week 24 photographs according to the following scale: Clear (no lesion); Psoriasis almost cleared; Mild psoriasis; Mild to moderate psoriasis; Moderate psoriasis; Moderate to severe psoriasis; Severe psoriasis. | Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. | Posted | Number | participants | Baseline and Week 24 |
|
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| Secondary | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score | The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100. | Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. | Posted | Mean | Full Range | percent change | Baseline and Weeks 4, 8, 16 and 24 |
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| Primary | Percentage of Participants With 75% Reduction in PASI Score | The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome). | Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. | Posted | Number | percentage of participants | Baseline and Weeks 4, 8, 16 and 24 |
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| Secondary | Percent Change From Baseline in Work Productivity and Activity Impairment | The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):
Each domain score ranges from 0 (no impairment) to 100 (complete impairment). Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value * 100. | Participants who received treatment with anti-TNF agents and completed study follow-up visits through to Week 24. The first 3 domains (work time missed, work impairment and overall loss of work productivity) were assessed on a sub-group of participants who had full time jobs (n=30). | Posted | Mean | Full Range | percent change | Baseline and Week 24 |
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| Secondary | Number of Participants With Adverse Events (AEs) | The number of participants experiencing any adverse event or a serious adverse event during the study are summarized. A serious AE is an event that results in death, is life-threatening, requires or prolongs hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity or is an important medical event that may require medical or surgical intervention to prevent any of the outcomes listed above. Please see the Adverse Event module below for additional details. | All enrolled participants. | Posted | Number | participants | 24 Weeks |
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24 weeks.
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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 | Anti-TNF | Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines. | 3 | 103 | 7 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatotoxicity, Toxic Hepatitis | Gastrointestinal disorders | MedDRA version 12.0 | Systematic Assessment |
| |
| Gangrenous emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA version 12.0 | Systematic Assessment |
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| Catheter infection, infected endocarditis | Infections and infestations | MedDRA version 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA version 12.0 | Systematic Assessment |
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Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Week 24 |
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