A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study Overview
Brief Summary
The purpose of the study is to determine the long term safety of Enbrel in adults with active rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in rheumatology practice patients. All patients initiated with Enbrel will be observed from the start of the study in Feb 2003 for a period of at least 5 years.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have moderate to severe active rheumatoid arthritis
- •Be aged of 17 years or more
- •Have inadequate response to DMards
- •Give written informed consent
- •Physician decides to prescribe Enbrel
Exclusion Criteria
- Not provided
Arms & Interventions
1
This is an open label, observational study.This is a post-marketing surveillance study in rheumatology practice patients in Luxemburg.Rheumatologists will be asked to document safety and adherence to therapy of Enbrel when given to adults with active rheumatoid arthritis.All patients initiated with Enbrel will be observed.
Intervention: etanercept (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to Month 66
Any untoward medical occurrence in a participant who received study treatment 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.
Secondary Outcomes
- Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66(Baseline, Months 6, 12, 18, 30, 42, 54 and 66)
- Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66(Baseline, Months 6, 12, 18, 30, 42, 54 and 66)
- Mean Dose of Concomitant Methotrexate (MTX) and Steroids(Baseline up to Month 66)
- Percentage of Participants With Completion of Study Treatment(Month 12 through Month 72)