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

NCT01262534 | Completed

• 2 other identifiers: CR017545CNTO1275PSO4013
• Study Type: observational
• Target: 1,042
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Psoriasis; comorbidities, associated treatment, quality of life

Study Arms (3)

1

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

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).

Other: Quality of Life

3

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

Other: Patient Preferences about treatment

Interventions

Clinical profile of patients OTHER

Comorbidities and associated type of treatments will be collected.

1

Patient Preferences about treatment OTHER

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

3

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).

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

MeSH Terms

Conditions

Psoriasis

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

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

  Janssen-Cilag, S.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 6, 2013

Record last verified: 2013-05