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This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric patients who are prescribed Humira® as per physician's medical judgment in accordance with the approved Korean local label will be enrolled in the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With Pediatric CD | Participants with pediatric CD who have been prescribed Humira® (adalimumab) by the treating physician. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs | An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with their treatment. If an AE meets any of the following criteria, it is considered a serious AE: results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, is an important medical event requiring medical or surgical intervention to prevent serious outcome. An ADR label was used for an AE when causal relationship with a pharmaceutical drug could not be excluded. | From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]). |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric CD patients who have been prescribed Humira® by the treating physician
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| Name | Affiliation | Role |
|---|---|---|
| Eunjung Gu, MS | AbbVie korea | Study Director |
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| Label | URL |
|---|---|
| Regarding Medicine Information | View source |
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Case report forms were retrieved from 152 participants during the study period. Among these participants, 143 were included in the safety analysis population, excluding 9 participants who did not use the drug according to the approved indication or dosage.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Pediatric Crohn's Disease (CD) | Participants with pediatric CD prescribed Humira® by their treating physician. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Pediatric Crohn's Disease (CD) | Participants with pediatric CD prescribed Humira® by their treating physician. |
| 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)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs | An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with their treatment. If an AE meets any of the following criteria, it is considered a serious AE: results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, is an important medical event requiring medical or surgical intervention to prevent serious outcome. An ADR label was used for an AE when causal relationship with a pharmaceutical drug could not be excluded. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]). |
|
From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]).
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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 | Participants With Pediatric CD | Participants with pediatric CD prescribed Humira® by their treating physician. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2017 | May 17, 2018 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C536215 | Pediatric Crohn's disease |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Participants with pediatric CD prescribed Humira® by their treating physician. |
|
|
| 0 |
| 143 |
| 8 |
| 143 |
| 22 |
| 143 |
| Gastrointestinal necrosis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Intestinal stenosis | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Colonic haematoma | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
| Anastomotic complication | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.0) | Non-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.