Clinical trial NCT02274363: A Study to Assess the Severity of Psoriasis in Brazilians Participants With Chronic Plaque-type Psoriasis
Official title: Assessment of Psoriasis Severity in Brazilians Patients With Chronic Plaque-type Psoriasis Attending Outpatient Clinics: a Multicenter, Observational, and Cross-sectional Study (APPISOT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Plaque
Keywords: Psoriasis
Plaque
Chronic
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 1131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Participant's Psoriasis Severity
timeFrame: At single study visit anytime between 6 to 12 months
Secondary outcomes:
measure: Participant Current Psoriasis Severity
timeFrame: At single study visit anytime between 6 to 12 months
measure: Disease Duration
timeFrame: Time from disease diagnosis to inclusion (up to 12 months)
measure: Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: At single study visit anytime between 6 to 12 months
measure: Brief Pain Inventory (BPI) Scale Score
timeFrame: At single study visit anytime between 6 to 12 months
measure: Health Related Quality of Life (HRQoL) Score
timeFrame: At single study visit anytime between 6 to 12 months
measure: Number of Participants With Alcohol Abuse
timeFrame: At single study visit anytime between 6 to 12 months
measure: Number of Participants With Comorbidities
timeFrame: At single stuy visit anytime between 6 to 12 months
Other outcomes:
Locations:
city: Belem
country: Brazil
city: Belo Horizonte
country: Brazil
city: Botucatu
country: Brazil
city: Brasilia
country: Brazil
city: Campinas
country: Brazil
city: Curitiba
country: Brazil
city: Fortaleza
country: Brazil
city: Goiania
country: Brazil
city: Joao Pessoa
country: Brazil
city: Porto Alegre
country: Brazil
city: Ribeirão Preto
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Santo Andre
country: Brazil
city: Sao Jose Do Rio Preto
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical Trial
role: STUDY_DIRECTOR
References: