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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 103 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Psoriasis

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-05-20
• Last updated: 2012-10-25
• Results posted: 2012-10-11

Locations

25 sites across 1 country: Turkey (Türkiye)