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| Name | Class |
|---|---|
| Innovex, Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Month 66 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Completion of Study Treatment | 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. |
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Inclusion Criteria:
Exclusion Criteria:
n/a
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Patients will be included after the physician decided to prescribe Enbrel.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Luxembourg | L-2420 | Luxembourg |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications. |
| 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 | 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. | Full analysis set (FAS) included all recruited participants who were either initiated or were already receiving etanercept. | Posted | Number | percentage of participants | Baseline up to Month 66 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angioneurotic oedema | General disorders | No coding system | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy | General disorders | No coding system | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| 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). | Baseline, Months 6, 12, 18, 30, 42, 54 and 66 |
| Mean Dose of Concomitant Methotrexate (MTX) and Steroids | Baseline up to Month 66 |
| Early closure of the site |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Completion of Study Treatment | FAS included all recruited participants who were either initiated or were already receiving etanercept. | Posted | Number | percentage of participants | Month 12 through Month 72 |
|
|
|
| Secondary | 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. | FAS included all recruited participants who were either initiated or were already receiving etanercept. The 'n' is signifying those participants who were evaluated for this measure at the specified time points. | Posted | Mean | Standard Deviation | joints | Baseline, Months 6, 12, 18, 30, 42, 54 and 66 |
|
|
|
| Secondary | 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). | FAS included all recruited participants who were either initiated or were already receiving etanercept. 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for this measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Months 6, 12, 18, 30, 42, 54 and 66 |
|
|
|
| Secondary | Mean Dose of Concomitant Methotrexate (MTX) and Steroids | Data was not analyzed due to low number of participants. | Posted | Mean | Standard Deviation | milligram (mg) | Baseline up to Month 66 |
|
|
| 6 |
| 25 |
| 13 |
| 25 |
| Myocardial infarction | General disorders | No coding system | Non-systematic Assessment |
|
| Leucopenia | General disorders | No coding system | Non-systematic Assessment |
|
| Neutropenia | General disorders | No coding system | Non-systematic Assessment |
|
| Liver function test abnormal | General disorders | No coding system | Non-systematic Assessment |
|
| Knee arthroplasty | General disorders | No coding system | Non-systematic Assessment |
|
| Breast cancer | General disorders | No coding system | Non-systematic Assessment |
|
| Fatigue | General disorders | No coding system | Non-systematic Assessment |
|
| General discomfort with hypotension | General disorders | No coding system | Non-systematic Assessment |
|
| Injection site reaction | General disorders | No coding system | Non-systematic Assessment |
|
| Sleep Trouble | General disorders | No coding system | Non-systematic Assessment |
|
| Vertigo | General disorders | No coding system | Non-systematic Assessment |
|
| Fracture left clavicle | General disorders | No coding system | Non-systematic Assessment |
|
| Osteoporosis fractures | General disorders | No coding system | Non-systematic Assessment |
|
| Synoviorthesis knee | General disorders | No coding system | Non-systematic Assessment |
|
| High blood pressure | General disorders | No coding system | Non-systematic Assessment |
|
| Constipation | General disorders | No coding system | Non-systematic Assessment |
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| Diarrhea | General disorders | No coding system | Non-systematic Assessment |
|
| Flatulence | General disorders | No coding system | Non-systematic Assessment |
|
| Increased hepatic enzymes | General disorders | No coding system | Non-systematic Assessment |
|
| Rectorragies | General disorders | No coding system | Non-systematic Assessment |
|
| Increased intra-ocular pressure | General disorders | No coding system | Non-systematic Assessment |
|
| Ocular dryness | General disorders | No coding system | Non-systematic Assessment |
|
| Aphtosis | General disorders | No coding system | Non-systematic Assessment |
|
| Buccal dryness | General disorders | No coding system | Non-systematic Assessment |
|
| Hypersensitivity tooth | General disorders | No coding system | Non-systematic Assessment |
|
| Bronchopneumopathy recurrent | General disorders | No coding system | Non-systematic Assessment |
|
| Dyspnea | General disorders | No coding system | Non-systematic Assessment |
|
| Pulmonary oedema | General disorders | No coding system | Non-systematic Assessment |
|
| Laryngitis | General disorders | No coding system | Non-systematic Assessment |
|
| Sinusitis | General disorders | No coding system | Non-systematic Assessment |
|
| Pruritus | General disorders | No coding system | Non-systematic Assessment |
|
| Nose and skin bleeding | General disorders | No coding system | Non-systematic Assessment |
|
| Zona | General disorders | No coding system | 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 |
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| Greater than 30 months to 36 months |
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| Greater than 36 months to 42 months |
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| Greater than 42 months to 48 months |
|
| Greater than 48 months to 54 months |
|
| Greater than 54 months to 60 months |
|
| Greater than 60 months to 66 months |
|
| Greater than 66 months to 72 months |
|
| Greater than 72 months |
|
| Title | Measurements |
|---|---|
|
| Change at Month 18 (n= 19) |
|
| Change at Month 30 (n= 22) |
|
| Change at Month 42 (n= 20) |
|
| Change at Month 54 (n= 18) |
|
| Change at Month 66 (n= 13) |
|
| Title | Measurements |
|---|---|
|
| Change at Month 18 (n= 10) |
|
| Change at Month 30 (n= 11) |
|
| Change at Month 42 (n= 9) |
|
| Change at Month 54 (n= 8) |
|
| Change at Month 66 (n= 2) |
|