- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01126619
A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis
To Observe the Effectiveness and Safety of Anti-TNFs in Patients With Moderate to Severe Psoriasis
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Afyon, Turkey, 03000
- Site Reference ID/Investigator# 38780
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Ankara, Turkey, 06000
- Site Reference ID/Investigator# 27422
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Ankara, Turkey, 06000
- Site Reference ID/Investigator# 38776
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Ankara, Turkey, 06000
- Site Reference ID/Investigator# 38777
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Ankara, Turkey, 06100
- Site Reference ID/Investigator# 38763
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Aydin, Turkey, 09000
- Site Reference ID/Investigator# 38767
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Bursa, Turkey, 16000
- Site Reference ID/Investigator# 38769
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Edirne, Turkey, 22030
- Site Reference ID/Investigator# 38779
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Gaziantep, Turkey, 27000
- Site Reference ID/Investigator# 38782
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Hatay, Turkey, 31000
- Site Reference ID/Investigator# 38778
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Isparta, Turkey, 32000
- Site Reference ID/Investigator# 38786
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Istanbul, Turkey, 34000
- Site Reference ID/Investigator# 38765
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Istanbul, Turkey, 34093
- Site Reference ID/Investigator# 38771
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Istanbul, Turkey, 34390
- Site Reference ID/Investigator# 38766
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Istanbul, Turkey, 34668
- Site Reference ID/Investigator# 38770
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Izmir, Turkey, 35000
- Site Reference ID/Investigator# 38764
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Kirikkale, Turkey, 71100
- Site Reference ID/Investigator# 44102
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Kocaeli, Turkey, 41380
- Site Reference ID/Investigator# 44104
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Konya, Turkey, 42000
- Site Reference ID/Investigator# 38781
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Malatya, Turkey, 44000
- Site Reference ID/Investigator# 38773
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Manisa, Turkey, 45000
- Site Reference ID/Investigator# 38768
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Mersin, Turkey, 33000
- Site Reference ID/Investigator# 38772
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Samsun, Turkey, 55139
- Site Reference ID/Investigator# 44262
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Sivas, Turkey, 58140
- Site Reference ID/Investigator# 44103
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Zonguldak, Turkey, 67600
- Site Reference ID/Investigator# 44105
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female patients ≥18 years old with moderate-to-severe psoriasis.
- Patients for whom the physician has decided to initiate psoriasis treatment with anti-TNFs in accordance with Turkish Ministry of Health regulations and reimbursements.
- Patients who are able to understand and answer a self administered questionnaire.
- Patients signed an informed consent form stating that they agreed to have their photographs taken, analyzed, and included in a scientific publication.
Exclusion Criteria:
- Patients who do not consent to being photographed during the study.
- Females who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study.
- Patients with untreated tuberculosis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Time Frame: Baseline and Weeks 4, 8, 16 and 24
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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.
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Baseline and Weeks 4, 8, 16 and 24
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Percentage of Participants With 75% Reduction in PASI Score
Time Frame: Baseline and Weeks 4, 8, 16 and 24
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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).
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Baseline and Weeks 4, 8, 16 and 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Dynamic Physician Global Assessment (PGA) of Change in Psoriasis
Time Frame: Baseline and Week 24
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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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Baseline and Week 24
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Dynamic Patient Global Assessment (PGA) of Change in Psoriasis
Time Frame: Baseline and Week 24
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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).
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Baseline and Week 24
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Static Physician Global Assessment (PGA) of Psoriasis
Time Frame: Baseline and Week 24
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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
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Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Time Frame: Baseline and Weeks 4, 8, 16 and 24
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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
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Percent Change From Baseline in Work Productivity and Activity Impairment
Time Frame: Baseline and Week 24
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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
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Number of Participants With Adverse Events (AEs)
Time Frame: 24 Weeks
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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
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mahmut Gucuk, MD, Abbott Laboratories Ithalat, Ithalat ve Tic. Ltd. Sti
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P12-130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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