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Completed

NCT Number: NCT01262534

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical profile of patients

Other

Comorbidities and associated type of treatments will be collected.

Patient Preferences about treatment

Other

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

Quality of life

Other

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 and collaborators

Lead sponsor

Janssen-Cilag, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2010
Registry last updated
May 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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