Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etanercept + methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Drug | according to SmPC and clinical practice |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Visit 4 (Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
patients with rheumatoid arthritis who fulfill the inclusion/exclusion criteria
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G. Gennimatas General Hospital /Rheumatology Clinic | Athens | Attica | 11527 | Greece | ||
| Ippokrateio General Hospital of Athens / 2nd internal Medicine Clinic of the University of Athens |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ETANERCEPT/ METHOTREXATE | The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ETANERCEPT/ METHOTREXATE | The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Last observation carried forward (LOCF) was applied where data were available. Participants where a EULAR response value could not be calculated, were omitted from the analysis. Only 48 Participants had available EULAR response data at 6 months. | Posted | Number | participants | Visit 4 (Month 6) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ETANERCEPT/ METHOTREXATE | The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcerative keratitis | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
| methotrexate |
| Drug |
according to SmPC and clinical practice |
|
| 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. | 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) | Baseline and Visit 4 (Month 6) |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6) | 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. | 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. | 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. | Baseline and Visit 4 (Month 6) |
| Athens |
| Attica |
| 11527 |
| Greece |
| University General Hospital of Heraklion | Heraklion | Creete | 71110 | Greece |
| G. Papanikolaoy | Thessaloniki | Exochi | 570 10 | Greece |
| 424 Military Hospital | Thessaloniki | Thessalonikis | Greece |
| Euromedica Kyanous Stavros | Thessaloniki | Thessaloniki | 54636 | Greece |
| Laiko General Peripheral Hospital | Athens | 115 27 | Greece |
| Peripheral University General Hospital of Larissa | Larissa | 41 222 | Greece |
| "Olympion therapeutic center" General Clinic of Patras | Pátrai | 26443 | Greece |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | The analysis was based on the Full Analysis Set (FAS) population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose. | Posted | Mean | Standard Deviation | Joints | Baseline and Visit 4 (Month 6) |
|
|
|
| Secondary | 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. | The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose. | Posted | Mean | Standard Deviation | Joints | Baseline and Visit 4 (Month 6) |
|
|
|
| Secondary | 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) | The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose. | Posted | Mean | Standard Deviation | mm | Baseline and Visit 4 (Month 6) |
|
|
|
| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6) | The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose. | Posted | Mean | Standard Deviation | mm/hour | Baseline and Visit 4 (Month 6) |
|
|
|
| Secondary | 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. | The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose. | Posted | Mean | Standard Deviation | units on scale | Baseline and Visit 4 (Month 6) |
|
|
|
| Secondary | 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. | The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose. | Posted | Mean | Standard Deviation | units on scale | Baseline and Visit 4 (Month 6) |
|
|
|
| Secondary | 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. | The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose. | Posted | Number | 95% Confidence Interval | Odds Ratio (per unit increase) | Baseline and Visit 4 (Month 6) |
|
|
|
| 6 |
| 76 |
| 14 |
| 76 |
| Injection site pruritus | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |