Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis

Study Overview
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Brief Summary
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The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.

Official Title
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A Post-Marketing Surveillance For Safety And Adherence To Treatment Of Enbrel In Adults With Psoriatic Arthritis In Belgium

Conditions
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Arthritis, Psoriatic

Intervention / Treatment
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* Other: Questionnaire
* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type At least 18 years old Have fulfilled reimbursement criteria for Enbrel in psoriatic arthritis of poly-articular type or oligo-articular type Physician decides to prescribe Enbrel or patient is already on Enbrel Give written informed consent at time of inclusion to study Exclusion Criteria: NA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PsA Patients (New)<br>New patients | Other: Questionnaire<br>* This is a non-interventional study<br>|
| PsA Patients<br>CU patients | Other: Questionnaire<br>* This is a non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Year 1 | 
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Year 1 up to Year 2 | 
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Year 2 up to Year 3 | 
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Year 3 up to Year 4 | 
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Year 4 up to Year 5 | 
| Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Year 5 up to Year 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least 1 Adverse Event (AE) Per Year | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Baseline up to Year 6 | 
| Incidence of Adverse Events and Serious Adverse Events Per Participant-Year | Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period. | Baseline up to Month 6, 12, 18, 30, 42, 54, 66 | 
| Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment |  | Baseline up to Month 78 | 
| Number of Joints With Active Arthritis | Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 | 
| Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation | Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated. | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 | 
| Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation | Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated. | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 | 
| Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA) | HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations. | Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmarketing surveillance, Enbrel, psoriatic arthritis