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

23. mars 2017 oppdatert av: Janssen Pharmaceutica

Assessment of Psoriasis Severity in Brazilians Patients With Chronic Plaque-type Psoriasis Attending Outpatient Clinics: a Multicenter, Observational, and Cross-sectional Study (APPISOT)

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

1131

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Brasil
      • Belem, Brasil
      • Belo Horizonte, Brasil
      • Botucatu, Brasil
      • Brasilia, Brasil
      • Campinas, Brasil
      • Curitiba, Brasil
      • Fortaleza, Brasil
      • Goiania, Brasil
      • Joao Pessoa, Brasil
      • Porto Alegre, Brasil
      • Ribeirão Preto, Brasil
      • Rio De Janeiro, Brasil
      • Salvador, Brasil
      • Santo Andre, Brasil
      • Sao Jose Do Rio Preto, Brasil
      • Sao Paulo, Brasil

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Tverrsnitt

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Participant's Psoriasis Severity
Tidsramme: At single study visit anytime between 6 to 12 months
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Participant Current Psoriasis Severity
Tidsramme: At single study visit anytime between 6 to 12 months
Psoriasis severity will be graded as mild or moderate to severe based on psoriasis area and severity index (PASI) score or on the dermatology life quality index (DLQI) or on body surface area (BSA). Participants with a score greater than (>) 10 in any of these scales will be reported as moderate to severe psoriasis. Participants with a PASI score less than or equal to (<=) 10 will be reported as mild psoriasis. Assessment should consider the participant's status at inclusion.
At single study visit anytime between 6 to 12 months
Disease Duration
Tidsramme: Time from disease diagnosis to inclusion (up to 12 months)
Disease duration is the time from disease diagnosis to inclusion in the study.
Time from disease diagnosis to inclusion (up to 12 months)
Hospital Anxiety and Depression Scale (HADS) Score
Tidsramme: At single study visit anytime between 6 to 12 months
The HADS has been developed to identify symptoms of anxiety and depression in hospitalized participants and in outpatients. It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety will be defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 = no anxiety; >9 = anxiety; HADS (depression): 8-8 = no depression; >9 = depression.
At single study visit anytime between 6 to 12 months
Brief Pain Inventory (BPI) Scale Score
Tidsramme: At single study visit anytime between 6 to 12 months
The presence of pain or discomfort over the past week will be assessed using the BPI. The BPI consists of 9 items related to pain (items 3 to 6) and the impact of pain/discomfort (items 9a to 9g) on general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. Each item is assessed on an 11-point scale varying from zero (no pain or no impact) to 10 (worst possible pain/worst possible impact). The items cover the dimensions of pain/discomfort severity and impact, and the scores are calculated from the means of each item, and may range from 0 to 10. The higher the score, the worse is the pain/discomfort and the perceived impact.
At single study visit anytime between 6 to 12 months
Health Related Quality of Life (HRQoL) Score
Tidsramme: At single study visit anytime between 6 to 12 months
The HRQoL will be assessed using 36-Item Short-Form Health Survey (SF-36), to assess global HRQoL; and the Dermatology Life Quality Index (DLQI) to assess quality of life specifically related to dermatological conditions. The SF-36 comprises 36 questions divided in 8 domains: physical functioning (10 items), role-physical (4 items), bodily pain (2 items), general health (5 items), vitality (4 items), social functioning (2 items), role-emotional (3 items), mental health (5 items), and a question for comparative assessment of current health status with that of the previous year. The domain-specific scores range from 0 (worst status) to 100 (best status). 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.
At single study visit anytime between 6 to 12 months
Number of Participants With Alcohol Abuse
Tidsramme: At single study visit anytime between 6 to 12 months
Disorders related to alcohol abuse will be investigated using the cut down, annoyed by criticism, guilty and eye-opener (CAGE) questionnaire. CAGE is a brief questionnaire that comprises four questions to be answered affirmatively or negatively. Two affirmative answers warrant a screening for alcohol abuse or dependence.
At single study visit anytime between 6 to 12 months
Number of Participants With Comorbidities
Tidsramme: At single stuy visit anytime between 6 to 12 months
Comorbidity refers to the presence of co-existing or additional diseases with reference to an initial diagnosis or with reference to the index condition that is the subject of study. Participants with Crohn's disease, systemic arterial hypertension, hyperlipidemia, arthritis, obesity, pruritus/burning sensation, depression, ulcerative colitis, metabolic syndrome, neoplasia, diabetes mellitus, ischemic disease and other cardiovascular disorders will be reported.
At single stuy visit anytime between 6 to 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Pharmaceutica

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. april 2012

Primær fullføring (Faktiske)

31. mai 2013

Studiet fullført (Faktiske)

31. mai 2013

Datoer for studieregistrering

Først innsendt

22. oktober 2014

Først innsendt som oppfylte QC-kriteriene

22. oktober 2014

Først lagt ut (Anslag)

24. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR100727
  • CNTO1275PSY0001 (Annen identifikator: Janssen Pharmaceutica)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

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