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| ID | Type | Description | Link |
|---|---|---|---|
| B1801130 |
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This surveillance is conducted to survey the followings under the post marketed drug utilization on the patients who are administrated ENBREL as a treatment for active polyarticular JIA.
All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept (genetical recombination) | All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2.5 year). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept (genetical recombination) | Drug | All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events of Etanercept | Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. | 24 weeks |
| Number of Participants With Serious Treatment-Related Adverse Events of Etanercept | Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder. | 24 weeks |
| Number of Unlisted Treatment-Related Adverse Events of Etanercept | Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment-related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert. | 24 weeks |
| Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Improvement On Physician's Assessment. | Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yokohama City University School of | Tokyo | Japan | Japan |
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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 (Genetical Recombination) | Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept (Genetical Recombination) | Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Number of Participants With Treatment-Related Adverse Events of Etanercept | Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. | The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted. | Posted | Number | participants | 24 weeks |
|
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The frequency of treatment related adverse events 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 (Genetical Recombination) | Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema infectiosum | Infections and infestations | MedDRA-J 15.1 | 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 |
|---|---|
| D001171 | Arthritis, Juvenile |
| 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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|
| 24 weeks |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Serious Treatment-Related Adverse Events of Etanercept | Serious treatment-related adverse events are defined as any events that lead to death, life-thretening, hospitalization or prolonged hospitalization, a permanent or remarkable disorder/dysfunction, congenital anormaly/congenital deficiency, or other medically significant events or disorder. | The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted. | Posted | Number | participants | 24 weeks |
|
|
|
| Primary | Number of Unlisted Treatment-Related Adverse Events of Etanercept | Adverse events are all unfavorable events, including clinically problematic abnormal changes in laboratory test values, which develop in participants after the administration of Etanercept, irrespective of causal relationship to Etanercept. The causal relationship between an adverse event and Etanercept was evaluated by the sponsor. Unlisted treatment-related adverse events were confirmed with listed adverse drug reactions specified in Japanese package insert. | The safety analysis population consisted of the participants who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection indicated for polyarticular JIA after the marketing authorization had been granted. | Posted | Number | events | 24 weeks |
|
|
|
| Primary | Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 | The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1. | The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 weeks |
|
|
|
| Secondary | Percentage of Participants With Overall Improvement On Physician's Assessment. | Percentage of participants in whom the efficacy of etanercept was assessed as either markedly effective or effective. | The efficacy analysis population consisted of the participants in whom DAS28 (4/ESR) was calculated (N = number of participants evaluated). The last observation carried forward (LOCF) method was used to impute missing data. | Posted | Number | 95% Confidence Interval | percent | 24 weeks |
|
|
|
| 1 |
| 102 |
| 27 |
| 102 |
| Gastroenteritis | Infections and infestations | MedDRA-J 15.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA-J 15.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA-J 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA-J 15.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA-J 15.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA-J 15.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Iritis | Eye disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA-J 15.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA-J 15.1 | Systematic Assessment |
|
| Blood beta-D-glucan increased | Investigations | MedDRA-J 15.1 | 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 |
| Title | Measurements |
|---|---|
|
| At 16 weeks (N = 32) |
|
| At 20 weeks (N = 34) |
|
| At 24 weeks (N = 46) |
|
| Title | Measurements |
|---|---|
|
| At 16 weeks (N = 65) |
|
| At 20 weeks (N = 67) |
|
| At 24 weeks (N = 83) |
|