Clinical trial NCT01964443: Clinical Assessment and Psychosocial Impact of Psoriasis
Official title: EPidemiological Study In Patients With Recently DiagnosEd PSOriasis: Clinical Assessment and Psychosocial Impact of This Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Plaque Psoriasis
Alexithymia
Quality of life
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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 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).

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: prevalence of alexithymia
timeFrame: Baseline
Secondary outcomes:
measure: psoriasis disease duration
timeFrame: baseline, month 6 and month 12
measure: psoriasis disease severity
timeFrame: baseline, month 6 and month 12
measure: anxiety and depression
timeFrame: baseline, month 6 and month 12
measure: problematic drinking
timeFrame: baseline, month 6 and month 12
measure: smoking
timeFrame: baseline, month 6 and month 12
measure: physical and mental/emotional quality of life
timeFrame: baseline, month 6 and month 12
measure: work and activity impairment related to psoriasis
timeFrame: baseline, month 6 and month 12
measure: alexithymia prevalence rate
timeFrame: month 6 and month 12
Other outcomes:
Locations:
city: Graz
country: Austria
city: Wien N/A
country: Austria
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Liège
country: Belgium
city: Mons
country: Belgium
city: Brest
country: France
city: Martigues
country: France
city: Nice Cedex 3
country: France
city: Pierre Benite Cedex
country: France
city: Reims Cedex
country: France
city: Rouen
country: France
city: Toulouse
country: France
city: Vandoeuvre Les Nancy
country: France
city: Athens
country: Greece
city: Heraklion
country: Greece
city: Thessalonikis
country: Greece
city: Thessaloniki
country: Greece
city: Dublin
country: Ireland
city: Galway
country: Ireland
city: Afula
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petah Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Tel Aviv
country: Israel
city: Alkmaar
country: Netherlands
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Nijmegen
country: Netherlands
city: Bergen
country: Norway
city: Tromsoe
country: Norway
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: Bloemfontein
country: South Africa
city: Durban
country: South Africa
city: Albacete
country: Spain
city: Alcorcon
country: Spain
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Bilbao Vizcaya
country: Spain
city: Santander
country: Spain
city: Valencia
country: Spain
city: Cardiff
country: United Kingdom
city: Dundee
country: United Kingdom
city: London
country: United Kingdom
city: Salford
country: United Kingdom
Study officials:
References: