Clinical trial NCT01126619: A Study of Effectiveness and Safety of Tumor Necrosis Factor (TNF) Inhibitors in Patients With Moderate to Severe Psoriasis
Official title: To Observe the Effectiveness and Safety of Anti-TNFs in Patients With Moderate to Severe Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-05-20
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University hospitals in Turkey

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
timeFrame: Baseline and Weeks 4, 8, 16 and 24
measure: Percentage of Participants With 75% Reduction in PASI Score
timeFrame: Baseline and Weeks 4, 8, 16 and 24
Secondary outcomes:
measure: Dynamic Physician Global Assessment (PGA) of Change in Psoriasis
timeFrame: Baseline and Week 24
measure: Dynamic Patient Global Assessment (PGA) of Change in Psoriasis
timeFrame: Baseline and Week 24
measure: Static Physician Global Assessment (PGA) of Psoriasis
timeFrame: Baseline and Week 24
measure: Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline and Weeks 4, 8, 16 and 24
measure: Percent Change From Baseline in Work Productivity and Activity Impairment
timeFrame: Baseline and Week 24
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Afyon
country: Turkey
facility: Site Reference ID/Investigator# 38780
city: Ankara
country: Turkey
facility: Site Reference ID/Investigator# 27422
city: Ankara
country: Turkey
facility: Site Reference ID/Investigator# 38776
city: Ankara
country: Turkey
facility: Site Reference ID/Investigator# 38777
city: Ankara
country: Turkey
facility: Site Reference ID/Investigator# 38763
city: Aydin
country: Turkey
facility: Site Reference ID/Investigator# 38767
city: Bursa
country: Turkey
facility: Site Reference ID/Investigator# 38769
city: Edirne
country: Turkey
facility: Site Reference ID/Investigator# 38779
city: Gaziantep
country: Turkey
facility: Site Reference ID/Investigator# 38782
city: Hatay
country: Turkey
facility: Site Reference ID/Investigator# 38778
city: Isparta
country: Turkey
facility: Site Reference ID/Investigator# 38786
city: Istanbul
country: Turkey
facility: Site Reference ID/Investigator# 38765
city: Istanbul
country: Turkey
facility: Site Reference ID/Investigator# 38771
city: Istanbul
country: Turkey
facility: Site Reference ID/Investigator# 38766
city: Istanbul
country: Turkey
facility: Site Reference ID/Investigator# 38770
city: Izmir
country: Turkey
facility: Site Reference ID/Investigator# 38764
city: Kirikkale
country: Turkey
facility: Site Reference ID/Investigator# 44102
city: Kocaeli
country: Turkey
facility: Site Reference ID/Investigator# 44104
city: Konya
country: Turkey
facility: Site Reference ID/Investigator# 38781
city: Malatya
country: Turkey
facility: Site Reference ID/Investigator# 38773
city: Manisa
country: Turkey
facility: Site Reference ID/Investigator# 38768
city: Mersin
country: Turkey
facility: Site Reference ID/Investigator# 38772
city: Samsun
country: Turkey
facility: Site Reference ID/Investigator# 44262
city: Sivas
country: Turkey
facility: Site Reference ID/Investigator# 44103
city: Zonguldak
country: Turkey
facility: Site Reference ID/Investigator# 44105
Study officials:
affiliation: Abbott Laboratories Ithalat, Ithalat ve Tic. Ltd. Sti
name: Mahmut Gucuk, MD
role: STUDY_DIRECTOR
References: