Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

N/ACompletedNCT00195338

Pfizer25 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

etanerceptDRUG

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Luxembourg, Luxembourg

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Time frame: Baseline up to Month 66

Secondary Outcomes

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

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.

Time frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66

Change From Baseline in Health Assessment Questionnaire (HAQ) Score at 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).

Time frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66

Mean Dose of Concomitant Methotrexate (MTX) and Steroids

Time frame: Baseline up to Month 66

Data from ClinicalTrials.gov

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