Chronic Plaque Psoriasis (Ps) Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients with Chronic Plaque Psoriasis (Ps).

Detailed Description
-----------------
ESPRIT is a 10 year registry of patients taking HUMIRA® for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with HUMIRA®. No registry specific testing will be performed. Patients will be asked to provide data on their experiences with HUMIRA® approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry.

Official Title
-----------------
A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS)

Conditions
-----------------
Chronic Plaque Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An adult patient (18 years of age or older) with chronic plaque psoriasis who has been prescribed HUMIRA® therapy according to the local product labeling and meets one of the following criteria: New initiated (within 4 weeks of registry entry) on HUMIRA® therapy; Initiated HUMIRA® therapy in the past and: Has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy and the physician can provide source documentation of SAEs, AEs, of Special Interest, and dosing information since initiation of therapy. OR Is entering after participation in an AbbVie HUMIRA (adalimumab) sponsored study and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy after the completion of AbbVie sponsored study and physician can provide source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of commercial HUMIRA® (defined as a prescribed/non study drug). Patient is willing to consent to data being collected and provided to AbbVie; Patient is capable of and willing to give written informed consent and to comply with the requirements of the registry. Exclusion Criteria: - Patient should not be enrolled if he/she cannot be treated in accordance with the local product label.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>This registry will evaluate the long-term safety and effectiveness of HUMIRA® as used in routine clinical practice. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Adverse Events | Incidence of Adverse Events is calculated upon all events that occur during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process. | Duration of study | 
| Incidence of Adverse Events of Special Interest | Incidence of Adverse Events is calculated upon all events that occur during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process. | Duration of study | 
| Adverse Events that lead to permanent discontinuation of HUMIRA® | Incidence of Adverse Events that lead to permanent discontinuation of HUMIRA® is calculated upon all events that lead to permanent discontinuation of HUMIRA® during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process. | Duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Care Utilization |  | Duration of study | 
| Work Productivity and Activity Impairment Questionnaire: Specific Health Problem |  | Duration of study | 
| Patient Global Assessment |  | Duration of study | 
| Patient Health Question-9 |  | Duration of study | 
| Medical Outcomes Social Activities Scale |  | Duration of study | 
| Patient reported outcome - Dermatology Life Quality Index |  | Duration of study | 
| Census |  | Duration of study | 
| Psoriasis Impact and Experience |  | Duration of study | 
| Illness Cognition |  | Duration of study | 
| Insurance Status |  | Duration of study | 
| Rosenberg Self-Esteem Scale |  | Duration of study | 
| Physician's Global Assessment |  | Collected approximately every six months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Moderate Psoriasis, Severe Psoriasis, Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis, Registry