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Trial record 5 of 1714 for:    psoriasis

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

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ClinicalTrials.gov Identifier: NCT02274363
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica

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.

Condition or disease Intervention/treatment
Psoriasis Plaque Other: No Intervention

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.

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Study Type : Observational
Actual Enrollment : 1131 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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)
Actual Study Start Date : April 10, 2012
Actual Primary Completion Date : May 31, 2013
Actual Study Completion Date : May 31, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Participant's Psoriasis Severity [ Time Frame: 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).


Secondary Outcome Measures :
  1. Participant Current Psoriasis Severity [ Time Frame: 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.

  2. Disease Duration [ Time Frame: Time from disease diagnosis to inclusion (up to 12 months) ]
    Disease duration is the time from disease diagnosis to inclusion in the study.

  3. Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: 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.

  4. Brief Pain Inventory (BPI) Scale Score [ Time Frame: 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.

  5. Health Related Quality of Life (HRQoL) Score [ Time Frame: 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.

  6. Number of Participants With Alcohol Abuse [ Time Frame: 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.

  7. Number of Participants With Comorbidities [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274363


Locations
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Brazil
Belem, Brazil
Belo Horizonte, Brazil
Botucatu, Brazil
Brasilia, Brazil
Campinas, Brazil
Curitiba, Brazil
Fortaleza, Brazil
Goiania, Brazil
Joao Pessoa, Brazil
Porto Alegre, Brazil
Ribeirão Preto, Brazil
Rio De Janeiro, Brazil
Salvador, Brazil
Santo Andre, Brazil
Sao Jose Do Rio Preto, Brazil
Sao Paulo, Brazil
Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
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Study Director: Janssen Pharmaceutica Clinical Trial Janssen Pharmaceutica

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Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT02274363     History of Changes
Other Study ID Numbers: CR100727
CNTO1275PSY0001 ( Other Identifier: Janssen Pharmaceutica )
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Janssen Pharmaceutica:
Psoriasis
Plaque
Chronic
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases