This open-label, prospective, observational study will evaluate the clinical response to etanercept + methotrexate therapy in patients with moderate to severe rheumatoid arthritis, as prescribed by the rheumatologist in a normal clinical setting in Greece
All subjects enrolled should meet the usual prescribing criteria for Etanercept as per the local product information and should be entered into the study at the investigator's discretion
Study Type
OBSERVATIONAL
Enrollment
76
according to SmPC and clinical practice
according to SmPC and clinical practice
G. Gennimatas General Hospital /Rheumatology Clinic
Athens, Attica, Greece
Ippokrateio General Hospital of Athens / 2nd internal Medicine Clinic of the University of Athens
Athens, Attica, Greece
University General Hospital of Heraklion
Heraklion, Creete, Greece
Primary: Participants With EULAR (Good)
Good European League Against Rheumatism (EULAR) response at 6 months based on DAS28 EULAR response criteria defined as Good response = DAS28 change \>1.2 with DAS28 ≤3.2; Moderate response = DAS28 change \>0.6 with DAS28 \>3.2-5.1; Non-response = DAS28 change ≤0.6 and absolute DAS28 \>5.1
Time frame: Visit 4 (Month 6)
Change From Baseline in Tender Joint Count at Visit 4 (Month 6)
In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was 'Present'. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.
Time frame: Baseline and Visit 4 (Month 6)
Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)
In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was 'Present'. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.
Time frame: Baseline and Visit 4 (Month 6)
Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6)
The patients used a 100 mm Visual Analogue Scale (VAS) to score their general health during the last week. The scale ranged from 0 (no pain) to 100 mm (severe pain)
Time frame: Baseline and Visit 4 (Month 6)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)
Time frame: Baseline and Visit 4 (Month 6)
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G. Papanikolaoy
Thessaloniki, Exochi, Greece
424 Military Hospital
Thessaloniki, Thessalonikis, Greece
Euromedica Kyanous Stavros
Thessaloniki, Thessaloniki, Greece
Laiko General Peripheral Hospital
Athens, Greece
Peripheral University General Hospital of Larissa
Larissa, Greece
"Olympion therapeutic center" General Clinic of Patras
Pátrai, Greece
Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)
The European Quality of Life-5 Dimensions (EQ-5D) was measured on a 5 item scale. The scores for the 5 items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) ranged from 1 (no problem) to 3 (extreme problems). For EQ-5D, participants rate questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each of the 5 dimensions is divided into 3 levels of perceived problems: Level 1=no problem; level 2=some problem; level 3=extreme problem. A unique health state is defined by combining 1 level from each dimension. A total of 243 possible health states are defined in this way. Each state is referred to in terms of a 5 digit code. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline and Visit 4 (Month 6)
Change From Baseline in HAQ-DI at Visit 4 (Month 6)
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is composed of 20 items. It is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score ranges from 0-3: 0=least difficulty and 3=extreme difficulty.
Time frame: Baseline and Visit 4 (Month 6)
Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)
In a first step a univariate logistic regression model was fit for the following baseline variables: DAS28 (n=48), Physician's Global Assessment of Disease Activity (VAS) (n=47), Patient's Global Assessment of Disease Activity (VAS) (n=47), CRP (n=46), Patient Pain (VAS) (n=47), HAQ-DI (n=47), EQ-5D (n=47). Only those variables that were significant at a 10% level were then included in the second step: a multivariate analysis with stepwise regression (entry level=10%, stay level=5%). The final model presented in the Basic Results table displays those covariates which were significant at the 2-sided 5% level (baseline value for DAS28; n=48). Note that DAS28 is not a categorical variable; therefore no stratified results for this variable are presented.
Time frame: Baseline and Visit 4 (Month 6)