An observational study in Pediatric Crohn's Disease, sponsored by AbbVie. Completed. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by AbbVie · Observational
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 143 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pediatric CD patients who have been prescribed Humira® by the treating physician
Exclusion Criteria:
Participants with pediatric CD who have been prescribed Humira® (adalimumab) by the treating physician.
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]).
| Milestone | Participants With Pediatric Crohn's Disease (CD) |
|---|---|
| Started | 143 |
| Completed | 143 |
| Not completed | 0 |
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.
| percentage of participants | Participants With Pediatric Crohn's Disease (CD) |
|---|---|
| AEs | 18.18 (12.23 to 25.49) |
| ADRs | 14.69 (9.33 to 21.57) |
| Serious AEs | 5.59 (2.45 to 10.73) |
| Serious ADRs | 3.50 (1.14 to 7.97) |
| Unexpected AEs | 6.29 (2.92 to 11.61) |
| Unexpected ADRs | 2.80 (0.77 to 7.01) |
Collected over 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]).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Pediatric CD | 0/143 (0%) | 8/143 (5.6%) | 22/143 (15.4%) |
| Event | Participants With Pediatric CD |
|---|---|
| Abdominal painGastrointestinal disorders | 2/143 |
| Gastrointestinal necrosisGastrointestinal disorders | 1/143 |
| HaematocheziaGastrointestinal disorders | 1/143 |
| Ileus paralyticGastrointestinal disorders | 1/143 |
| Intestinal obstructionGastrointestinal disorders | 1/143 |
| Intestinal perforationGastrointestinal disorders | 1/143 |
| Small intestinal obstructionGastrointestinal disorders | 1/143 |
| AppendicitisInfections and infestations | 1/143 |
| PeritonitisInfections and infestations | 1/143 |
| PyrexiaGeneral disorders | 1/143 |
| Event | Participants With Pediatric CD |
|---|---|
| LeukopeniaBlood and lymphatic system disorders | 4/143 |
| RashSkin and subcutaneous tissue disorders | 3/143 |
| Alanine aminotransferase increasedInvestigations | 3/143 |
| Aspartate aminotransferase increasedInvestigations | 3/143 |
| DiarrhoeaGastrointestinal disorders | 2/143 |
| Intestinal stenosisGastrointestinal disorders | 2/143 |
| HaematocheziaGastrointestinal disorders | 1/143 |
| Colonic haematomaGastrointestinal disorders | 1/143 |
| Gastrointestinal inflammationGastrointestinal disorders | 1/143 |
| PruritusSkin and subcutaneous tissue disorders | 1/143 |
| Age, Continuous(years) | Participants With Pediatric Crohn's Disease (CD) |
|---|---|
| Mean | 14.14 ± 2.43 |
| Sex: Female, Male(Participants) | Participants With Pediatric Crohn's Disease (CD) |
|---|---|
| Female | 56 |
| Male | 87 |
| Race/Ethnicity, Customized(Participants) | Participants With Pediatric Crohn's Disease (CD) |
|---|---|
| Korean | 143 |
No study locations are listed for this record.
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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