MedDataX Logo

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

NCT ID: NCT01126619

Last Updated: 2012-10-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mahmut Gucuk, MD

Role: STUDY_DIRECTOR

Abbott Laboratories Ithalat, Ithalat ve Tic. Ltd. Sti

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 38780

Afyonkarahisar, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 27422

Ankara, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38776

Ankara, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38777

Ankara, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38763

Ankara, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38767

Aydin, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38769

Bursa, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38779

Edirne, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38782

Gaziantep, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38778

Hatay, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38786

Isparta, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38765

Istanbul, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38771

Istanbul, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38766

Istanbul, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38770

Istanbul, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38764

Izmir, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 44104

Kocaeli, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38781

Konya, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 44102

Kırıkkale, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38773

Malatya, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38768

Manisa, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 38772

Mersin, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 44262

Samsun, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 44103

Sivas, , Turkey (Türkiye)

Site Status

Site Reference ID/Investigator# 44105

Zonguldak, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P12-130

Identifier Type: -

Identifier Source: org_study_id