An observational study in Rheumatoid Arthritis, sponsored by Pfizer. Completed at 9 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-11.
Sponsored by Pfizer · Observational
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
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 76 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
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patients with rheumatoid arthritis who fulfill the inclusion/exclusion criteria
Exclusion Criteria:
Drug: etanercept · Drug: methotrexate
according to SmPC and clinical practice
according to SmPC and clinical practice
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)
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)
| Milestone | ETANERCEPT/ METHOTREXATE |
|---|---|
| Started | 76 |
| Completed | 63 |
| Not completed | 13 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Withdrawal by subject | 6 |
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
| participants | Etanercept/Methotrexate |
|---|---|
| Primary: Participants With EULAR (Good) | 19 |
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.
| Joints | Etanercept/Methotrexate |
|---|---|
| Change From Baseline in Tender Joint Count at Visit 4 (Month 6) | -7.68 ± 7.08 |
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.
| Joints | Etanercept/Methotrexate |
|---|---|
| Change From Baseline in Swollen Joint Count at Visit 4 (Month 6) | -4.52 ± 5.22 |
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)
| mm | Etanercept/Methotrexate |
|---|---|
| Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6) | -38.14 ± 28.79 |
| mm/hour | Etanercept/Methotrexate |
|---|---|
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6) | -21.21 ± 22.28 |
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.
| units on scale | Etanercept/Methotrexate |
|---|---|
| Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6) | 0.40 ± 0.36 |
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.
| units on scale | Etanercept/Methotrexate |
|---|---|
| Change From Baseline in HAQ-DI at Visit 4 (Month 6) | -0.78 ± 0.63 |
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.
| Odds Ratio (per unit increase) | Etanercept/Methotrexate |
|---|---|
| Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF) | 2.831 (1.358 to 5.898) |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ETANERCEPT/ METHOTREXATE | — | 6/76 (7.9%) | 14/76 (18.4%) |
| Event | ETANERCEPT/ METHOTREXATE |
|---|---|
| Ulcerative keratitisEye disorders | 1/76 |
| Injection site pruritusGeneral disorders | 1/76 |
| Gallbladder disorderHepatobiliary disorders | 1/76 |
| GastroenteritisInfections and infestations | 1/76 |
| Lower respiratory tract infectionInfections and infestations | 1/76 |
| Respiratory tract infectionInfections and infestations | 1/76 |
| MyopathyMusculoskeletal and connective tissue disorders | 1/76 |
| HeadacheNervous system disorders | 1/76 |
| ThrombosisVascular disorders | 1/76 |
| Event | ETANERCEPT/ METHOTREXATE |
|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 3/76 |
| VertigoEar and labyrinth disorders | 2/76 |
| DiarrhoeaGastrointestinal disorders | 2/76 |
| Drug ineffectiveGeneral disorders | 2/76 |
| Injection site erythemaGeneral disorders | 2/76 |
| Injection site pruritusGeneral disorders | 2/76 |
| ArthritisMusculoskeletal and connective tissue disorders | 2/76 |
| AlopeciaSkin and subcutaneous tissue disorders | 2/76 |
| Age, Continuous(years) | ETANERCEPT/ METHOTREXATE |
|---|---|
| Mean | 55.5 ± 14.3 |
| Sex: Female, Male(Participants) | ETANERCEPT/ METHOTREXATE |
|---|---|
| Female | 66 |
| Male | 10 |
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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