Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis

Study Overview
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Brief Summary
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This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.

Detailed Description
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Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC). Patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site.

Official Title
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Open Label Study To Evaluate The Safety Profile And The Quality Of Life In Patients Receiving Etanercept For The Treatment Of Rheumatoid Arthritis, Ankylosing Spondylitis And Psoriatic Arthritis

Conditions
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Ankylosing Spondylitis, Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondylitis, Ankylosing

Intervention / Treatment
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* Other: There is no Intervention. The study is observational.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older at time of consent Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis or has a diagnosis of ankylosing spondylitis or psoriatic arthritis, as determined by the doctor Provides informed consent Demonstrate a negative serum or urine pregnancy test prior to administration of etanercept. Sexually active women participating in the study must use a medically acceptable form of contraception. Patients already prescribed etanercept according to approved labelling Exclusion Criteria: Has hypersensitivity to etanercept Has sepsis or risk of sepsis. Treatment with etanercept should not be initiated in patients with active infections (ie. hepatitis C, hepatitis B, active TBC) Is pregnant or breast-feeding Has significant concurrent medical diseases including, uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, or central nervous system (CNS) demyelinating events suggestive of multiple sclerosis Has a history of confirmed blood dyscrasias Received any live (attenuated) vaccines within 4 weeks of screening visit

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 |
| --- | --- |
| etanercept<br>Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC). | Other: There is no Intervention. The study is observational.<br>* The study is observational and the prescription follows the SmPC of etanercept.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Month 24 | 
| Number of Participants Who Discontinued Treatment |  | Baseline up to Month 24 | 
| Number of Participants by Reasons for Discontinuation of Treatment |  | Baseline up to Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation. | Baseline, Month 24 | 
| Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month | PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. | Baseline, Month 24 | 
| Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month | PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible. | Baseline, Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis