PsoriasisNCT02274363
A Study to Assess the Severity of Psoriasis in Brazilians Participants With Chronic Plaque-type Psoriasis
An observational study of Psoriasis and Plaque, run by Janssen Pharmaceutica at 16 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 1,131 participants
- Where
- 16 sitesBrazil
- Study dates
- 10 Apr 2012to 31 May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants at least 18 years of age with chronic plaque psoriasis under outpatient follow-up will be included irrespective of disease severity.
Who may be able to join
- Participant diagnosed with chronic plaque psoriasis
- Participant is at least 18 years old
- Participant is able to understand and sign the Informed Consent Form
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Brazil16 sites
Study site
Belém
Study site
Belo Horizonte
Study site
Botucatu
Study site
Brasília
Study site
Campinas
Study site
Curitiba
Study site
Fortaleza
Study site
Goiânia
Study site
João Pessoa
Study site
Porto Alegre
Study site
Ribeirão Preto
Study site
Rio de Janeiro
Study site
Salvador
Study site
Santo André
Study site
São José do Rio Preto
Study site
São Paulo
About this study
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)
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.
Read the 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.
- Being tested
- No Intervention
- Keywords
- Psoriasis, Plaque, Chronic
- Medical subject headings
- Psoriasis, Plaque, Amyloid, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At single study visit anytime between 6 to 12 months
Secondary outcomes (7)
Participant Current Psoriasis Severity
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.
Measured: At single study visit anytime between 6 to 12 months
Disease Duration
Disease duration is the time from disease diagnosis to inclusion in the study.
Measured: Time from disease diagnosis to inclusion (up to 12 months)
Hospital Anxiety and Depression Scale (HADS) Score
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.
Measured: At single study visit anytime between 6 to 12 months
Brief Pain Inventory (BPI) Scale Score
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.
Measured: At single study visit anytime between 6 to 12 months
Health Related Quality of Life (HRQoL) Score
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.
Measured: At single study visit anytime between 6 to 12 months
Number of Participants With Alcohol Abuse
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.
Measured: At single study visit anytime between 6 to 12 months
Number of Participants With Comorbidities
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.
Measured: At single stuy visit anytime between 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study start10 Apr 2012
- Primary completion31 May 2013
- Study completion31 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica Clinical Trial, Study director, Janssen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274363
- Sponsor's protocol ID
- CR100727
- Other IDs
- CNTO1275PSY0001
- Status last verified
- Mar 2017
- First submitted
- 22 Oct 2014
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02274363
- Acronym / sponsor ID
- CR100727
- Keywords
- Psoriasis, Plaque, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,131 participants (actual)
- Lead sponsor
- Janssen PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2012 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 31 May 2013 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brazilian Participants with Chronic Plaque-type Psoriasis | – | Other: No InterventionBrazilian participants with plaque psoriasis followed up at teaching and non-teaching specialized dermatology centers will be included in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants at least 18 years of age with chronic plaque psoriasis under outpatient follow-up will be included irrespective of disease severity.
Key inclusion criteria (3 listed)
- Participant diagnosed with chronic plaque psoriasis
- Participant is at least 18 years old
- Participant is able to understand and sign the Informed Consent Form
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionParticipants 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. | Other | Brazilian Participants with Chronic Plaque-type Psoriasis |
Primary outcome
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).
7 secondary outcomes
Participant Current Psoriasis Severity
Time frame: At single study visit anytime between 6 to 12 months
Disease Duration
Time frame: Time from disease diagnosis to inclusion (up to 12 months)
Hospital Anxiety and Depression Scale (HADS) Score
Time frame: At single study visit anytime between 6 to 12 months
Brief Pain Inventory (BPI) Scale Score
Time frame: At single study visit anytime between 6 to 12 months
Health Related Quality of Life (HRQoL) Score
Time frame: At single study visit anytime between 6 to 12 months
Number of Participants With Alcohol Abuse
Time frame: At single study visit anytime between 6 to 12 months
Number of Participants With Comorbidities
Time frame: At single stuy visit anytime between 6 to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutica Clinical Trial study director
Janssen Pharmaceutica
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Plaque, run by Janssen Pharmaceutica at 16 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant's Psoriasis Severity (time frame: At single study visit anytime between 6 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.