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

NCT01126619 | Completed Results

• 1 other identifier: P12-130
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 25

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.

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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

• Percentage of Participants With 75% Reduction in PASI Score

  The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).

  Baseline and Weeks 4, 8, 16 and 24

Secondary Outcomes (6)

• Dynamic Physician Global Assessment (PGA) of Change in Psoriasis

  Baseline and Week 24

• Dynamic Patient Global Assessment (PGA) of Change in Psoriasis

  Baseline and Week 24

• Static Physician Global Assessment (PGA) of Psoriasis

  Baseline and Week 24

• Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score

  Baseline and Weeks 4, 8, 16 and 24

• Percent Change From Baseline in Work Productivity and Activity Impairment

  Baseline and Week 24

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University hospitals in Turkey

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (25)

Site Reference ID/Investigator# 38780

Afyonkarahisar, 03000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 27422

Ankara, 06000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38776

Ankara, 06000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38777

Ankara, 06000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38763

Ankara, 06100, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38767

Aydin, 09000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38769

Bursa, 16000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38779

Edirne, 22030, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38782

Gaziantep, 27000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38778

Hatay, 31000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38786

Isparta, 32000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38765

Istanbul, 34000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38771

Istanbul, 34093, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38766

Istanbul, 34390, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38770

Istanbul, 34668, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38764

Izmir, 35000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 44104

Kocaeli, 41380, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38781

Konya, 42000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 44102

Kırıkkale, 71100, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38773

Malatya, 44000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38768

Manisa, 45000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 38772

Mersin, 33000, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 44262

Samsun, 55139, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 44103

Sivas, 58140, Turkey (Türkiye)

Location

Site Reference ID/Investigator# 44105

Zonguldak, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Mahmut Gucuk, MD

  Abbott Laboratories Ithalat, Ithalat ve Tic. Ltd. Sti

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 20, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 25, 2012
• Results First Posted: October 11, 2012

Record last verified: 2012-10

Locations

TU (25)