Clinical Assessment and Psychosocial Impact of Psoriasis

NCT ID: NCT01964443

Last Updated: 2015-12-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 719 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-11-30

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).

Conditions

Psoriasis

Keywords

Plaque Psoriasis; Alexithymia; Quality of life

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Graz, , Austria

Vienna, , Austria

Edegem, , Belgium

Ghent, , Belgium

Liège, , Belgium

Mons, , Belgium

Brest, , France

Martigues, , France

Nice, , France

Pierre-Bénite, , France

Reims, , France

Rouen, , France

Toulouse, , France

Vandœuvre-lès-Nancy, , France

Athens, , Greece

Heraklion, , Greece

Thessaloniki, , Greece

Thessalonikis, , Greece

Dublin, , Ireland

Galway, , Ireland

Afula, , Israel

Haifa, , Israel

Jerusalem, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Tel Aviv, , Israel

Alkmaar, , Netherlands

Amsterdam, , Netherlands

Breda, , Netherlands

Nijmegen, , Netherlands

Bergen, , Norway

Tromsø, , Norway

Moscow, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Bloemfontein, , South Africa

Durban, , South Africa

Albacete, , Spain

Alcorcón, , Spain

Alicante, , Spain

Barcelona, , Spain

Bilbao Vizcaya, , Spain

Santander, , Spain

Valencia, , Spain

Cardiff, , United Kingdom

Dundee, , United Kingdom

London, , United Kingdom

Salford, , United Kingdom

Countries

Germany; Austria; Belgium; France; Greece; Ireland; Israel; Netherlands; Norway; Russia; South Africa; Spain; United Kingdom

Other Identifiers

CNTO1275PSO4034

Identifier Type: OTHER

Identifier Source: secondary_id

CR100972

Identifier Type: -

Identifier Source: org_study_id