Clinical trial NCT01262534: A Study to Assess the Clinical Profile of Patients in Spain With Moderate to Severe Psoriasis.
Official title: Observational Epidemiological Registry to Assess the Clinical Profile in Patients With Moderate to Severe Psoriasis in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
comorbidities, associated treatment, quality of life
Lead sponsor: Janssen-Cilag, S.A.
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 1042
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from hospital sites and out-patient dermatology clinics will participate under the conditions of standard clinical practice

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag, S.A.
name: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial
role: STUDY_DIRECTOR
References: