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

Abbott

Status: Completed

Conditions: Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT01126619

P12-130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

103 participants in 1 patient group

Anti-TNF

Description:

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.