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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01262534
Enrollment
1042
Registered
2010-12-17
Start date
2010-10-31
Completion date
2011-06-30
Last updated
2013-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis, comorbidities, associated treatment, quality of life

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

Interventions

OTHERClinical profile of patients

Comorbidities and associated type of treatments will be collected.

OTHERPatient Preferences about treatment

Patient Benefit Index (PBI), for treatment to record patient preferences regarding psoriasis treatment.

OTHERQuality 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).

Sponsors

Janssen-Cilag, S.A.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026