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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT01262534
First received: December 16, 2010
Last updated: May 3, 2013
Last verified: May 2013

December 16, 2010
May 3, 2013
October 2010
June 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01262534 on ClinicalTrials.gov Archive Site
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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

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.

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

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Probability Sample

Patients from hospital sites and out-patient dermatology clinics will participate under the conditions of standard clinical practice

Psoriasis
  • Other: Clinical profile of patients
    Comorbidities and associated type of treatments will be collected.
  • Other: Patient Preferences about treatment
    Patient Benefit Index (PBI), for treatment to record patient preferences regarding psoriasis treatment.
  • Other: 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).
  • 1
    Clinical profile of patients Comorbidities and associated type of treatments will be collected.
    Intervention: Other: Clinical profile of patients
  • 2
    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).
    Intervention: Other: Quality of Life
  • 3
    Patient Preferences about treatment Patient Benefit Index (PBI) for treatment to record patient preferences regarding psoriasis treatment.
    Intervention: Other: Patient Preferences about treatment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1042
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01262534
CR017545, CNTO1275PSO4013
Not Provided
Janssen-Cilag, S.A.
Janssen-Cilag, S.A.
Not Provided
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
Janssen-Cilag, S.A.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP