Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis
- Conditions
- Arthritis, Psoriatic
- Interventions
- Other: Questionnaire
- Registration Number
- NCT00938015
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
- 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
NA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PsA Patients (New) Questionnaire New patients PsA Patients Questionnaire CU patients
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1 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.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2 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.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3 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.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4 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.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5 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.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With at Least 1 Adverse Event (AE) Per Year Baseline 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.
Incidence of Adverse Events and Serious Adverse Events Per Participant-Year Baseline up to Month 6, 12, 18, 30, 42, 54, 66 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.
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 Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 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.
Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 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.
Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 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.
Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA) Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Leuven, Belgium