PsoriasisEPIDEPSONCT01964443
Clinical Assessment and Psychosocial Impact of Psoriasis
An observational study of Psoriasis, run by Janssen Pharmaceutica N.V., Belgium at 48 sites in 12 countries.
Trial summary
The purpose of this study is to explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 719 participants
- Where
- 48 sitesin 12 countries
- Study dates
- Sep 2013to Nov 2015
- 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: Men and women, 18 years of age and older, who have had the onset of the first symptoms of plaque psoriasis less than 10 years before study entry, are naïve or experienced to topical treatment, and are eligible for phototherapy or systemic treatment
Who may be able to join
- Have onset of first symptoms of plaque psoriasis less than 10 years before baseline; Be either naïve or experienced to topical treatment; Be eligible for phototherapy or systemic treatment, as determined by the participating physician at the patient's baseline visit.
Who cannot join
- Has a history of or current treatment with a systemic agent (including biologic agents); Has non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular); Has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point.
Trial locations and contacts
48 sites in 12 countries.
48 sites in 12 countries
France8 sites
Study site
Brest
Study site
Martigues
Study site
Nice
Study site
Pierre-Bénite
Study site
Reims
Study site
Rouen
Study site
Toulouse
Study site
Vandœuvre-lès-Nancy
Spain7 sites
Study site
Albacete
Study site
Alcorcón
Study site
Alicante
Study site
Barcelona
Study site
Bilbao Vizcaya
Study site
Santander
Study site
Valencia
Israel6 sites
Study site
Afula
Study site
Haifa
Study site
Jerusalem
Study site
Petah Tikva
Study site
Ramat Gan
Study site
Tel Aviv
Belgium4 sites
Study site
Edegem
Study site
Ghent
Study site
Liège
Study site
Mons
Greece4 sites
Study site
Athens
Study site
Heraklion
Study site
Thessaloniki
Study site
Thessalonikis
Netherlands4 sites
Study site
Alkmaar
Study site
Amsterdam
Study site
Breda
Study site
Nijmegen
United Kingdom4 sites
Study site
Cardiff
Study site
Dundee
Study site
London
Study site
Salford
About this study
Official title: EPidemiological Study In Patients With Recently DiagnosEd PSOriasis: Clinical Assessment and Psychosocial Impact of This Disease
The purpose of this study is to explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the initial years of the psoriasis disease (longitudinal part).
Read the detailed description
This is a prospective, non-interventional, observational, multicenter study to document the prevalence of alexithymia in adult men and women, 18 years of age and older, who have had the onset of the first symptoms of plaque psoriasis less than 10 years before study entry, are naïve or experienced to topical treatment, and are eligible for phototherapy or systemic treatment. Only data available from routine clinical practice will be collected and all treatment decisions will be made at the discretion of the treating physician. Additionally, where local regulations permit, participating physicians will be asked to obtain Patient-Reported Outcome (PRO) data from patients participating in this observational study. A target of 800 adult patients will participate in this study at approximately 80 sites. The enrollment period of this study is expected to continue for approximately 9 months. Each patient will receive treatment as per standard clinical practice and will be followed up for 12 months. Therefore, the total duration of this observational study is expected to be approximately 21 months. Overall psoriasis disease severity as assessed by the physician will be documented at baseline (cross-sectional) and in the observational (longitudinal) phase of the study. Several outcomes related to psychosocial comorbidities (eg, alexithymia, anxiety, depression), addiction, and work and activity impairment as measured by PRO questionnaires and scales will also be collected. Information on psoriasis treatment(s) (topical, phototherapy, systemic [non-biologic, biologic]), mental health drugs (including those used for sleep), and concomitant medications given for comorbid medical conditions will also be collected. The data for this study will be analyzed and reported separately for the cross-sectional data (baseline) and for the longitudinal data (from baseline to Month 12).
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, Alexithymia, Quality of life
- Medical subject headings
- Psoriasis, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all included patients | Men and women, 18 years of age and older, who have had the onset of the first symptoms of plaque psoriasis less than 10 years before study entry, are naïve or experienced to topical treatment, and are eligible for phototherapy or systemic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of alexithymia
presence of alexithymia defined as 20-item Toronto Alexithymia Scale (TAS-20) score ≥61: TAS-20 is a validated self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale: 1 = strongly disagree, 2 = neither agree or disagree, 3 = undecided, 4 = agree, 5 = strongly agree. There are 3 subscales: difficulty describing feelings, difficulty identifying feelings, and externally oriented thinking. The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Measured: Baseline
Secondary outcomes (8)
psoriasis disease duration
Psoriasis Global Assessment (PGA): Overall lesions are graded for induration (from 0 = no evidence of plaque elevation to 5 = severe plaque elevation = 1.25 mm or more), erythema (from 0 = no evidence of erythema, hyperpigmentation may be present to 5 = dusky to deep red coloration), and scaling (from 0 = no evidence of scaling to 5 = severe; very thick tenacious scale predominates). The sum of the 3 scales is divided by 3 and rounded to obtain a final PGA score. The PGA final scores are defined as: 0 = cleared, except for residual discoloration; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; and 5 = severe.
Measured: baseline, month 6 and month 12
psoriasis disease severity
Psoriasis Area and Severity Index (PASI): system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 50 response is defined as ≥50% improvement in PASI score from baseline; PASI 75 and PASI 90 are similarly defined.
Measured: baseline, month 6 and month 12
anxiety and depression
Hospital Anxiety and Depression Scale (HADS; subscales: anxiety [-A], depression [-D]) is a validated 14-item scale with 7 of the items relating to anxiety and 7 relating to depression. Each item is scored from 0 to 3, with higher scores indicating greater likelihood of depression or anxiety. Cases of anxiety or depression are each defined by subscale scores of 8 or greater, and categorized as normal (score of 0 to 7), mild (score of 8 to 10), moderate (score of 11 to 14), and severe (score of 15 to 21). The recall period is the past week.
Measured: baseline, month 6 and month 12
problematic drinking
Alcohol Use Disorders Identification Test (AUDIT) consists of 10 questions about a patient's quantity and frequency of alcohol use. The response to 8 of the questions are scored as 0 = never, 1 = monthly or less, 2 = 2 to 4 times a month, 3 = 2 to 3 times a week, 4 = 4 or more times a week. Two questions are scored as 0 = no, 2 = yes, but not in the last year, 4 = yes, during the last year. A score of 8 or more is associated with harmful or hazardous drinking. In this study, the patient self-report questionnaire will be used
Measured: baseline, month 6 and month 12
smoking
number of cigarettes smoked per day
Measured: baseline, month 6 and month 12
physical and mental/emotional quality of life
Dermatology Life Quality Index (DLQI) is a dermatology-specific validated 10-question quality of life instrument. Each question addresses how much the patient's skin problem has affected their life and is scored as: 3 = very much, 2 = a lot, 1 = a little, 0 = not at all, or 0 = not relevant. The recall period is the past week. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more health-related quality of life is impaired: 0 to 1 = no effect at all on patient's life; 2 to 5 = small effect on patient's life; 6 to 10 = moderate effect on patient's life; 11 to 20 = very large effect on patient's life; 21 to 30 = extremely large effect on patient's life.
Measured: baseline, month 6 and month 12
work and activity impairment related to psoriasis
Work Productivity and Activity Impairment questionnaire:Psoriasis (WPAI:PSO) produces 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. The WPAI:PSO outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, ie, worse outcomes.
Measured: baseline, month 6 and month 12
alexithymia prevalence rate
Measured: month 6 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionNov 2015
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
- Prospective
- Enrolment
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964443
- Sponsor's protocol ID
- CR100972
- Other IDs
- CNTO1275PSO4034
- Acronym
- EPIDEPSO
- Status last verified
- Dec 2015
- First submitted
- 17 Sep 2013
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPidemiological Study In Patients With Recently DiagnosEd PSOriasis: Clinical Assessment and Psychosocial Impact of This Disease
- ClinicalTrials.gov ID
- NCT01964443
- Acronym / sponsor ID
- EPIDEPSO / CR100972
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, Alexithymia, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Oct 2013 (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 explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the initial years of the psoriasis disease (longitudinal part).
Detailed description
This is a prospective, non-interventional, observational, multicenter study to document the prevalence of alexithymia in adult men and women, 18 years of age and older, who have had the onset of the first symptoms of plaque psoriasis less than 10 years before study entry, are naïve or experienced to topical treatment, and are eligible for phototherapy or systemic treatment. Only data available from routine clinical practice will be collected and all treatment decisions will be made at the discretion of the treating physician. Additionally, where local regulations permit, participating physicians will be asked to obtain Patient-Reported Outcome (PRO) data from patients participating in this observational study. A target of 800 adult patients will participate in this study at approximately 80 sites. The enrollment period of this study is expected to continue for approximately 9 months. Each patient will receive treatment as per standard clinical practice and will be followed up for 12 months. Therefore, the total duration of this observational study is expected to be approximately 21 months. Overall psoriasis disease severity as assessed by the physician will be documented at baseline (cross-sectional) and in the observational (longitudinal) phase of the study. Several outcomes related to psychosocial comorbidities (eg, alexithymia, anxiety, depression), addiction, and work and activity impairment as measured by PRO questionnaires and scales will also be collected. Information on psoriasis treatment(s) (topical, phototherapy, systemic [non-biologic, biologic]), mental health drugs (including those used for sleep), and concomitant medications given for comorbid medical conditions will also be collected. The data for this study will be analyzed and reported separately for the cross-sectional data (baseline) and for the longitudinal data (from baseline to Month 12).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all included patients | – | –Men and women, 18 years of age and older, who have had the onset of the first symptoms of plaque psoriasis less than 10 years before study entry, are naïve or experienced to topical treatment, and are eligible for phototherapy or systemic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women, 18 years of age and older, who have had the onset of the first symptoms of plaque psoriasis less than 10 years before study entry, are naïve or experienced to topical treatment, and are eligible for phototherapy or systemic treatment
Key inclusion criteria (1 listed)
- Have onset of first symptoms of plaque psoriasis less than 10 years before baseline; Be either naïve or experienced to topical treatment; Be eligible for phototherapy or systemic treatment, as determined by the participating physician at the patient's baseline visit.
Key exclusion criteria (1 listed)
- Has a history of or current treatment with a systemic agent (including biologic agents); Has non-plaque forms of psoriasis (eg, erythrodermic, guttate, or pustular); Has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of alexithymia
Time frame: Baseline
presence of alexithymia defined as 20-item Toronto Alexithymia Scale (TAS-20) score ≥61: TAS-20 is a validated self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale: 1 = strongly disagree, 2 = neither agree or disagree, 3 = undecided, 4 = agree, 5 = strongly agree. There are 3 subscales: difficulty describing feelings, difficulty identifying feelings, and externally oriented thinking. The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
8 secondary outcomes
psoriasis disease duration
Time frame: baseline, month 6 and month 12
psoriasis disease severity
Time frame: baseline, month 6 and month 12
anxiety and depression
Time frame: baseline, month 6 and month 12
problematic drinking
Time frame: baseline, month 6 and month 12
smoking
Time frame: baseline, month 6 and month 12
physical and mental/emotional quality of life
Time frame: baseline, month 6 and month 12
work and activity impairment related to psoriasis
Time frame: baseline, month 6 and month 12
alexithymia prevalence rate
Time frame: month 6 and month 12
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 15 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Janssen Pharmaceutica N.V., Belgium at 48 sites in 12 countries.
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 1 inclusion and 1 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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in France, Spain, Israel, Belgium, Greece and 7 more countries. 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?
prevalence of alexithymia (time frame: Baseline). 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 15 Dec 2015.