Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
|ClinicalTrials.gov Identifier: NCT00195338|
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : January 23, 2012
Last Update Posted : January 23, 2012
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Drug: etanercept|
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg|
|Study Start Date :||May 2004|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2010|
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.
- 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.
- Percentage of Participants With Completion of Study Treatment [ Time Frame: Month 12 through Month 72 ]
- Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 [ Time Frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66 ]Synovitis was defined as the inflammation of a synovial (joint-lining) membrane, usually painful, particularly on motion, and characterized by swelling, due to effusion (fluid collection) in a synovial sac.
- Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 [ Time Frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66 ]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 possible score ranged from 0 (no difficulty) to 60 (unable to do).
- Mean Dose of Concomitant Methotrexate (MTX) and Steroids [ Time Frame: Baseline up to Month 66 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195338
|Pfizer Investigational Site|
|Luxembourg, Luxembourg, L-2420|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|