Pediatric Crohn's Disease
Conditions
Keywords
Korea, Humira, Pediatric Crohn's Disease
Brief summary
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients with CD who are prescribed Humira in accordance with the Korean label for Humira authorization (labeling) * Patients who have given written authorization to use their personal health data for the purposes of this study.
Exclusion criteria
* Any contraindications to Humira as listed on the approved product market authorization (labeling) * Patients who is participating on other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs | 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]). | 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. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Pediatric Crohn's Disease (CD) Participants with pediatric CD prescribed Humira® by their treating physician. | 143 |
| Total | 143 |
Baseline characteristics
| Characteristic | Participants With Pediatric Crohn's Disease (CD) |
|---|---|
| Age, Continuous | 14.14 years STANDARD_DEVIATION 2.43 |
| Race/Ethnicity, Customized Korean | 143 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 143 |
| other Total, other adverse events | 22 / 143 |
| serious Total, serious adverse events | 8 / 143 |
Outcome results
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.
Time frame: 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]).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Pediatric Crohn's Disease (CD) | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs | AEs | 18.18 percentage of participants |
| Participants With Pediatric Crohn's Disease (CD) | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs | ADRs | 14.69 percentage of participants |
| Participants With Pediatric Crohn's Disease (CD) | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs | Serious AEs | 5.59 percentage of participants |
| Participants With Pediatric Crohn's Disease (CD) | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs | Serious ADRs | 3.50 percentage of participants |
| Participants With Pediatric Crohn's Disease (CD) | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs | Unexpected AEs | 6.29 percentage of participants |
| Participants With Pediatric Crohn's Disease (CD) | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs | Unexpected ADRs | 2.80 percentage of participants |