To Observe the Effectiveness and Safety of Anti-TNFs 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.
Observational
Time Perspective: Prospective
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
No
Mahmut Gucuk, MD
Study Director
Abbott Laboratories Ithalat, Ithalat ve Tic. Ltd. Sti
Turkey: Ministry of Health
P12-130
NCT01126619
May 2010
September 2011
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