A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis
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|ClinicalTrials.gov Identifier: NCT01126619|
Recruitment Status : Completed
First Posted : May 20, 2010
Results First Posted : October 11, 2012
Last Update Posted : October 25, 2012
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||103 participants|
|Official Title:||To Observe the Effectiveness and Safety of Anti-TNFs in Patients With Moderate to Severe Psoriasis|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
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.
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [ Time Frame: Baseline and Weeks 4, 8, 16 and 24 ]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.
- Percentage of Participants With 75% Reduction in PASI Score [ Time Frame: Baseline and Weeks 4, 8, 16 and 24 ]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).
- Dynamic Physician Global Assessment (PGA) of Change in Psoriasis [ Time Frame: Baseline and Week 24 ]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).
- Dynamic Patient Global Assessment (PGA) of Change in Psoriasis [ Time Frame: Baseline and Week 24 ]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).
- Static Physician Global Assessment (PGA) of Psoriasis [ Time Frame: Baseline and Week 24 ]
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.
- Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score [ Time Frame: Baseline and Weeks 4, 8, 16 and 24 ]
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.
- Percent Change From Baseline in Work Productivity and Activity Impairment [ Time Frame: Baseline and Week 24 ]
The following parameters were assessed using the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO):
- Percent work time missed in the last 7 days due to problems associated with psoriasis;
- Percent impairment at work, based on the participant's assessment of how much psoriasis affected their productivity while they were working in the last 7 days;
- Percent overall loss of work productivity, based on hours missed and impairment while working due to psoriasis;
- Percent general activity impairment, based on the participant's assessment of how much psoriasis affected their ability to perform regular daily activities, such as work around the house, shopping, child care, exercising, studying, etc.
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.
- Number of Participants With Adverse Events (AEs) [ Time Frame: 24 Weeks ]
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.
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): NCT01126619
|Site Reference ID/Investigator# 38780|
|Afyon, Turkey, 03000|
|Site Reference ID/Investigator# 27422|
|Ankara, Turkey, 06000|
|Site Reference ID/Investigator# 38776|
|Ankara, Turkey, 06000|
|Site Reference ID/Investigator# 38777|
|Ankara, Turkey, 06000|
|Site Reference ID/Investigator# 38763|
|Ankara, Turkey, 06100|
|Site Reference ID/Investigator# 38767|
|Aydin, Turkey, 09000|
|Site Reference ID/Investigator# 38769|
|Bursa, Turkey, 16000|
|Site Reference ID/Investigator# 38779|
|Edirne, Turkey, 22030|
|Site Reference ID/Investigator# 38782|
|Gaziantep, Turkey, 27000|
|Site Reference ID/Investigator# 38778|
|Hatay, Turkey, 31000|
|Site Reference ID/Investigator# 38786|
|Isparta, Turkey, 32000|
|Site Reference ID/Investigator# 38765|
|Istanbul, Turkey, 34000|
|Site Reference ID/Investigator# 38771|
|Istanbul, Turkey, 34093|
|Site Reference ID/Investigator# 38766|
|Istanbul, Turkey, 34390|
|Site Reference ID/Investigator# 38770|
|Istanbul, Turkey, 34668|
|Site Reference ID/Investigator# 38764|
|Izmir, Turkey, 35000|
|Site Reference ID/Investigator# 44102|
|Kirikkale, Turkey, 71100|
|Site Reference ID/Investigator# 44104|
|Kocaeli, Turkey, 41380|
|Site Reference ID/Investigator# 38781|
|Konya, Turkey, 42000|
|Site Reference ID/Investigator# 38773|
|Malatya, Turkey, 44000|
|Site Reference ID/Investigator# 38768|
|Manisa, Turkey, 45000|
|Site Reference ID/Investigator# 38772|
|Mersin, Turkey, 33000|
|Site Reference ID/Investigator# 44262|
|Samsun, Turkey, 55139|
|Site Reference ID/Investigator# 44103|
|Sivas, Turkey, 58140|
|Site Reference ID/Investigator# 44105|
|Zonguldak, Turkey, 67600|
|Study Director:||Mahmut Gucuk, MD||Abbott Laboratories Ithalat, Ithalat ve Tic. Ltd. Sti|