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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Psoriasis
 Other: Clinical profile of patients
Other: Patient Preferences about treatment
Other: Quality of Life
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Observational Epidemiological Registry to Assess the Clinical Profile in Patients With Moderate to Severe Psoriasis in Spain

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Janssen-Cilag, S.A.:

Enrollment: 1042
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Clinical profile of patients Comorbidities and associated type of treatments will be collected.
 Other: Clinical profile of patients
Comorbidities and associated type of treatments will be collected.
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).
 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).
3
Patient Preferences about treatment Patient Benefit Index (PBI) for treatment to record patient preferences regarding psoriasis treatment.
 Other: Patient Preferences about treatment
Patient Benefit Index (PBI), for treatment to record patient preferences regarding psoriasis treatment.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262534

Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
  More Information

No publications provided

Responsible Party: Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier: NCT01262534     History of Changes
Other Study ID Numbers: CR017545, CNTO1275PSO4013
Study First Received: December 16, 2010
Last Updated: May 3, 2013
Health Authority: Spain: Spanish Drug Agency

Keywords provided by Janssen-Cilag, S.A.:
Psoriasis
comorbidities, associated treatment, quality of life

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on June 13, 2013