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

NCT02274363 | Completed FDA Drug

• 2 other identifiers: CR100727CNTO1275PSY0001
• Study Type: observational
• Target: 1,131
• Locations: 1 country
• Sites: 16

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.

Conditions

Psoriasis; Plaque

Keywords

Psoriasis; Plaque; Chronic

Outcome Measures

Primary Outcomes (1)

• Participant's Psoriasis Severity

  Psoriasis severity will be graded as mild or moderate to severe based on psoriasis area and severity index (PASI) score;combined assessment of lesion severity and area affected into single score. Body will be divided into 4 sections:head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated:0=0%, 1=less than (\<) 10%, 2=10 to \<30%, 3=30 to \<50%, 4=50 to \<70%, 5=70 to \<90%, 6=90 to 100%. Severity will be estimated by clinical signs:erythema,induration,desquamation;scale:0= none to 4=maximum. Final PASI=sum of severity parameters for each section\*area score\*weight of section (head:0.1,arms:0.2,body:0.3,legs:0.4);total possible score range: 0=no disease to 72=maximal disease or on the dermatology life quality index (DLQI);comprises 10 questions evaluated on a scale from 0 (not at all) to 3 (very much). The total scores may range from 0 to 30, with higher scores indicating a higher level of disability or on body surface area (BSA).

  At single study visit anytime between 6 to 12 months

Secondary Outcomes (7)

• Participant Current Psoriasis Severity

  At single study visit anytime between 6 to 12 months

• Disease Duration

  Time from disease diagnosis to inclusion (up to 12 months)

• Hospital Anxiety and Depression Scale (HADS) Score

  At single study visit anytime between 6 to 12 months

• Brief Pain Inventory (BPI) Scale Score

  At single study visit anytime between 6 to 12 months

• Health Related Quality of Life (HRQoL) Score

  At single study visit anytime between 6 to 12 months

Study Arms (1)

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.

Other: No Intervention

Interventions

No Intervention 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.

Brazilian Participants with Chronic Plaque-type Psoriasis

Eligibility Criteria

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

Study Population

Participants at least 18 years of age with chronic plaque psoriasis under outpatient follow-up will be included irrespective of disease severity.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica: lead

Study Sites (16)

Unknown Facility

Belém, Brazil

Location

Unknown Facility

Belo Horizonte, Brazil

Location

Unknown Facility

Botucatu, Brazil

Location

Unknown Facility

Brasília, Brazil

Location

Unknown Facility

Campinas, Brazil

Location

Unknown Facility

Curitiba, Brazil

Location

Unknown Facility

Fortaleza, Brazil

Location

Unknown Facility

Goiânia, Brazil

Location

Unknown Facility

João Pessoa, Brazil

Location

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Ribeirão Preto, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

Salvador, Brazil

Location

Unknown Facility

Santo André, Brazil

Location

Unknown Facility

São José do Rio Preto, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

MeSH Terms

Conditions

Psoriasis; Plaque, Amyloid; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Janssen Pharmaceutica Clinical Trial

  Janssen Pharmaceutica

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: April 10, 2012
• Primary Completion: May 31, 2013
• Study Completion: May 31, 2013
• Last Updated: March 27, 2017

Record last verified: 2017-03

Locations

BR (16)