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Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, underlying diseases and complications especially in regard to purified protein derivative (PPD) skin test, and chest X-ray. At routine visits for Humira Injection administration, which will occur according to usual medical practice, concomitant medication information and adverse events information will be collected for up to 70 days after the last administration of Humira.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Polyarticular JIA or ERA | Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. | Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment | Active Joint Count will be assessed and collected by participating investigators in routine medical practice. Sixty-eight joints were assessed by physical examination. Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Higher scores represent higher disease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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General hospital
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| Name | Affiliation | Role |
|---|---|---|
| Eunjung Gu, MS | AbbVie korea | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 600 participants were expected to enroll in the study; however, due to low prevalence of JIA and ERA, only 28 participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Polyarticular JIA or ERA | Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Polyarticular JIA or ERA | Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA) |
| 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 | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. | Safety analysis set: All participants who received at least one administration of Humira during the study (after informed consent or first administration of Humira) and for 70 days following the last scheduled administration of Humira. | Posted | Number | participants | Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks) |
Adverse Events (AEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 22 weeks); SAEs were collected from the time informed consent was obtained (22 weeks).
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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 | Patients With Polyarticular JIA or ERA | Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| From the first administration (Day 1) to approximately 12 weeks (±4 weeks) |
| Physician's Global Assessment of the Disease | The Physician's global assessment of the disease assessment was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.' | From the first administration (Day 1) to approximately 12 weeks (±4 weeks) |
| Parent's Global Assessment for Effectiveness | Parent's global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.' | From the first administration (Day 1) to approximately 12 weeks (±4 weeks) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Patients With Polyarticular JIA or ERA | Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA) |
|
|
| Secondary | Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment | Active Joint Count will be assessed and collected by participating investigators in routine medical practice. Sixty-eight joints were assessed by physical examination. Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Higher scores represent higher disease activity. | Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks. | Posted | Mean | Standard Deviation | active joint | From the first administration (Day 1) to approximately 12 weeks (±4 weeks) |
|
|
|
| Secondary | Physician's Global Assessment of the Disease | The Physician's global assessment of the disease assessment was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.' | Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks. | Posted | Number | participants | From the first administration (Day 1) to approximately 12 weeks (±4 weeks) |
|
|
|
| Secondary | Parent's Global Assessment for Effectiveness | Parent's global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.' | Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks. | Posted | Count of Participants | Participants | From the first administration (Day 1) to approximately 12 weeks (±4 weeks) |
|
|
|
| 1 |
| 28 |
| 6 |
| 28 |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Not assessable |
|
| Title | Measurements |
|---|---|
|
| Not assessable |
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