Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: etanercept

• Registration Number: NCT00195338
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-12
• Results First Submitted: 2011-12-16
• Results First Submitted QC: 2011-12-16
• Last Update Submitted: 2011-12-16
• Results First Posted: 2012-01-23
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

n/a

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	etanercept	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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 Outcome Measures

Name	Time	Method
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	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).
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	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.
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇱🇺 Luxembourg, Luxembourg