Trial Outcomes & Findings for Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination" (NCT NCT02578238)
NCT ID: NCT02578238
Last Updated: 2018-12-19
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
143 participants
Primary outcome timeframe
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]).
Results posted on
2018-12-19
Participant Flow
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.
Participant milestones
| Measure |
Participants With Pediatric Crohn's Disease (CD)
Participants with pediatric CD prescribed Humira® by their treating physician.
|
|---|---|
|
Overall Study
STARTED
|
143
|
|
Overall Study
COMPLETED
|
143
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"
Baseline characteristics by cohort
| Measure |
Participants With Pediatric Crohn's Disease (CD)
n=143 Participants
Participants with pediatric CD prescribed Humira® by their treating physician.
|
|---|---|
|
Age, Continuous
|
14.14 years
STANDARD_DEVIATION 2.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Korean
|
143 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With Pediatric Crohn's Disease (CD)
n=143 Participants
Participants with pediatric CD prescribed Humira® by their treating physician.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs
AEs
|
18.18 percentage of participants
Interval 12.23 to 25.49
|
|
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs
ADRs
|
14.69 percentage of participants
Interval 9.33 to 21.57
|
|
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
Interval 2.45 to 10.73
|
|
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
Interval 1.14 to 7.97
|
|
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
Interval 2.92 to 11.61
|
|
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
Interval 0.77 to 7.01
|
Adverse Events
Participants With Pediatric CD
Serious events: 8 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Pediatric CD
n=143 participants at risk
Participants with pediatric CD prescribed Humira® by their treating physician.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
2/143 • 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]).
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.70%
1/143 • 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]).
|
|
Gastrointestinal disorders
Haematochezia
|
0.70%
1/143 • 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]).
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.70%
1/143 • 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]).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.70%
1/143 • 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]).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.70%
1/143 • 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]).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.70%
1/143 • 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]).
|
|
Infections and infestations
Appendicitis
|
0.70%
1/143 • 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]).
|
|
Infections and infestations
Peritonitis
|
0.70%
1/143 • 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]).
|
|
General disorders
Pyrexia
|
0.70%
1/143 • 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]).
|
|
Infections and infestations
Candida infection
|
0.70%
1/143 • 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]).
|
|
Infections and infestations
Pyelonephritis acute
|
0.70%
1/143 • 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]).
|
Other adverse events
| Measure |
Participants With Pediatric CD
n=143 participants at risk
Participants with pediatric CD prescribed Humira® by their treating physician.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
2/143 • 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]).
|
|
Gastrointestinal disorders
Haematochezia
|
0.70%
1/143 • 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]).
|
|
Gastrointestinal disorders
Intestinal stenosis
|
1.4%
2/143 • 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]).
|
|
Gastrointestinal disorders
Colonic haematoma
|
0.70%
1/143 • 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]).
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.70%
1/143 • 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]).
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
3/143 • 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]).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.70%
1/143 • 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]).
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.70%
1/143 • 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]).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.70%
1/143 • 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]).
|
|
Investigations
Alanine aminotransferase increased
|
2.1%
3/143 • 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]).
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
3/143 • 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]).
|
|
Investigations
Liver function test abnormal
|
0.70%
1/143 • 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]).
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.8%
4/143 • 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]).
|
|
Infections and infestations
Helicobacter gastritis
|
0.70%
1/143 • 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]).
|
|
General disorders
Malaise
|
0.70%
1/143 • 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]).
|
|
General disorders
Pain
|
0.70%
1/143 • 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]).
|
|
Investigations
C-reactive protein increased
|
0.70%
1/143 • 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]).
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.70%
1/143 • 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]).
|
|
General disorders
Injection site erythema
|
0.70%
1/143 • 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]).
|
|
Infections and infestations
Folliculitis
|
0.70%
1/143 • 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]).
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.70%
1/143 • 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]).
|
|
Nervous system disorders
Dizziness
|
0.70%
1/143 • 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]).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER