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A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01126619
Recruitment Status : Completed
First Posted : May 20, 2010
Results First Posted : October 11, 2012
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Description
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Brief Summary:
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.

Condition or disease
Psoriasis

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 103 participants
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.


  4. 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.


  5. 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.


  6. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
University hospitals in Turkey
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Abbott
Investigators
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Study Director: Mahmut Gucuk, MD Abbott Laboratories Ithalat, Ithalat ve Tic. Ltd. Sti
More Information
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01126619    
Other Study ID Numbers: P12-130
First Posted: May 20, 2010    Key Record Dates
Results First Posted: October 11, 2012
Last Update Posted: October 25, 2012
Last Verified: October 2012
Keywords provided by Abbott:
Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases