A Study to Assess the Clinical Profile of Patients in Spain With Moderate to Severe Psoriasis.

Psoriasis Clinical Trial

Official title:

Observational Epidemiological Registry to Assess the Clinical Profile in Patients With Moderate to Severe Psoriasis in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262534
• Other study ID #: CR017545
• Secondary ID: CNTO1275PSO4013
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2010
• Last updated: May 3, 2013
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2013
• Source: Janssen-Cilag, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Drug Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the clinical profile of patients with moderate to severe psoriasis in Spain. The primary objective is to analyze the clinical profile of patients with moderate to severe psoriasis, as defined by a set of conditions (obesity, hypertension, diabetes, abnormal amounts of lipids in the blood, cardiovascular disease, etc.) and its correlation to the patients' quality of life. The secondary objectives are to describe the demographic characteristics and habits of the patient, to evaluate the clinical characteristics of the disease, and to describe the diagnostic and therapeutic procedures being used in standard clinical practice and the patients' expectations for these therapies.

Description:

This is an epidemiological, non-interventional, multi-centre, cross-sectional, retrospective, observational study to assess the clinical profile of patients with moderate to severe psoriasis in Spain. The data for each patient will be recorded only once, in one visit. During this visit the specialist will ask the patient a series of questions to describe the existence or absence of a number of conditions and their associated treatments, to record the characteristics of psoriasis experienced by the patient and the type of associated treatment. Not applicable

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1042
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years of age

• Diagnosed with psoriasis at least 6 months before the visit

• Diagnosed with moderate to severe psoriasis

• Who have been treated or not for moderate to severe psoriasis

• For whom the medical history dating back at least 6 months can be accessed

• the patient's legal representative has signed informed consent, stating that the patient understands the study purpose and requirements and grants the patient consent to participate in the study

Exclusion Criteria:

• Patient diagnosed with mild psoriasis according to the dermatologist or with a skin disease other than psoriasis

• With any type of difficulty understanding the questions in the DLQI, SF-36 and PBI questionnaires

• Who and/or whose legal representative refuses to grant written, informed consent to participate in the study

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• Clinical profile of patients
Comorbidities and associated type of treatments will be collected.
• Patient Preferences about treatment
Patient Benefit Index (PBI), for treatment to record patient preferences regarding psoriasis treatment.
• Quality of Life
The Quality of Life will be assessed by 2 questionnaires (SF-36 questionnaire, to analyze the overall quality of life of patients, and Dermatology Life Quality Index (DLQI), to analyze the quality of life of patients, in dermatological terms).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag, S.A.