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

NCT ID: NCT01262534

Last Updated: 2013-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1042 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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

Conditions

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Psoriasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Clinical profile of patients Comorbidities and associated type of treatments will be collected.

Clinical profile of patients

Intervention Type OTHER

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).

Quality of Life

Intervention Type 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).

3

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

Patient Preferences about treatment

Intervention Type OTHER

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

Interventions

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Clinical profile of patients

Comorbidities and associated type of treatments will be collected.

Intervention Type OTHER

Patient Preferences about treatment

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

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag, S.A.

Other Identifiers

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CNTO1275PSO4013

Identifier Type: OTHER

Identifier Source: secondary_id

CR017545

Identifier Type: -

Identifier Source: org_study_id

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