A Study to Assess the Severity of Psoriasis in Brazilians Participants With Chronic Plaque-type Psoriasis

NCT ID: NCT02274363

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1131 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-10
• Study Completion Date: 2013-05-31

Brief Summary

The purpose of this study is to assess the severity of plaque-type psoriasis (common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region) in brazilian participants with chronic plaque-type psoriasis.

Detailed Description

This is a cross-sectional (studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at one particular time), observational (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions), non-interventional, multicenter study (when more than one hospital or medical school team work on a medical research study). Participants with plaque psoriasis will be followed up at specialized dermatology centers. Participants will undergo assessment at a single time point and all assessments will be conducted on the same day. Information will be collected about disease severity/ socioeconomic variables and demographics; clinical characteristics; treatment (current and past procedures and therapies to treat psoriasis); quality of life; and comorbidities identified after plaque psoriasis was diagnosed. The information will be obtained from the medical records, as requested, and during the medical interviews. The primary objective of this study is to assess the severity of plaque-type psoriasis.

Conditions

Psoriasis; Plaque

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Brazilian Participants with Chronic Plaque-type Psoriasis

Brazilian participants with plaque psoriasis followed up at teaching and non-teaching specialized dermatology centers will be included in this study.

No Intervention

Intervention Type: OTHER

Participants will not receive any intervention in this study. Participants with chronic plaque type psoriasis will be assessed at a single time point, primarily for severity of plaque-type psoriasis Participants will not be followed over time. Data will be collected from the medical consultation notes, medical records and during interviews.

Interventions

No Intervention

Participants will not receive any intervention in this study. Participants with chronic plaque type psoriasis will be assessed at a single time point, primarily for severity of plaque-type psoriasis Participants will not be followed over time. Data will be collected from the medical consultation notes, medical records and during interviews.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participant diagnosed with chronic plaque psoriasis
• Participant is at least 18 years old
• Participant is able to understand and sign the Informed Consent Form

Exclusion Criteria

• In the opinion of the investigator, the participant is unable or unavailable to complete all study procedures
• Participant suffers from a psychiatric condition or any other clinical condition that might interfere with the ability to understand the study requirements
• Participant refuses consent or is unwilling to supply the required information within the required period
• Participant is taking part in an interventionist clinical trial with an investigational agent (i.e. non-commercialized agent) or in an interventionist clinical trial sponsored by Johnson & Johnson
• Participant is an employee of the investigator or study site and is directly involved in the conduction of this study or other studies conducted by the same investigator at the same site, or is a family member of the employee or investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica

Locations

Belém, , Brazil

Belo Horizonte, , Brazil

Botucatu, , Brazil

Brasília, , Brazil

Campinas, , Brazil

Curitiba, , Brazil

Fortaleza, , Brazil

Goiânia, , Brazil

João Pessoa, , Brazil

Porto Alegre, , Brazil

Ribeirão Preto, , Brazil

Rio de Janeiro, , Brazil

Salvador, , Brazil

Santo André, , Brazil

São José do Rio Preto, , Brazil

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

CNTO1275PSY0001

Identifier Type: OTHER

Identifier Source: secondary_id

CR100727

Identifier Type: -

Identifier Source: org_study_id