Trial Outcomes & Findings for Infliximab (Remicade) for Patients With Acute Kawasaki Disease (NCT NCT00271570)
NCT ID: NCT00271570
Last Updated: 2010-06-14
Results Overview
The safety of giving infliximab to treat IVIG-resistant Kawasaki disease was measured by recording the number of adverse events that occurred in each group. An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of either IVIG or infliximab, regardless of whether it was considered related to IVIG or infliximab, that occured during the course of this study.In particular we evaluated for AEs related to side effects from infliximab or IVIG.
COMPLETED
PHASE1
24 participants
2 weeks
2010-06-14
Participant Flow
Participant milestones
| Measure |
IVIG Arm (2 gr/kg)
2nd dose of IVIG (2gr/kg)
|
Infliximab (5mg/kg)
Remicade (Infliximab Arm of 5mg/kg)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Infliximab (Remicade) for Patients With Acute Kawasaki Disease
Baseline characteristics by cohort
| Measure |
IVIG Arm (2 gr/kg)
n=12 Participants
2nd dose of IVIG (2gr/kg)
|
Infliximab (5mg/kg)
n=12 Participants
Remicade (Infliximab Arm of 5mg/kg)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
1.833 years
STANDARD_DEVIATION .3 • n=5 Participants
|
1.667 years
STANDARD_DEVIATION .3 • n=7 Participants
|
1.75 years
STANDARD_DEVIATION .3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksThe safety of giving infliximab to treat IVIG-resistant Kawasaki disease was measured by recording the number of adverse events that occurred in each group. An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of either IVIG or infliximab, regardless of whether it was considered related to IVIG or infliximab, that occured during the course of this study.In particular we evaluated for AEs related to side effects from infliximab or IVIG.
Outcome measures
| Measure |
IVIG Arm (2 gr/kg)
n=12 Participants
2nd dose of IVIG (2gr/kg)
|
Infliximab (5mg/kg)
n=12 Participants
Remicade (Infliximab Arm of 5mg/kg)
|
|---|---|---|
|
Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)
|
2 events
|
3 events
|
PRIMARY outcome
Timeframe: before infliximab infusion and then 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion.The area under the curve (AUC) from time 0 to the last measurable concentration (AUC0-last) was estimated using the trapezoidal rule up to the last measurable concentration.Samples were collected before infliximab infusion and then at 2 and 24 hours, 1 week (5 to 9 days), 2 weeks (12 to 16 days), and 4 weeks (26 to 30 days) after infliximab infusion. Subjects with detectable infliximab concentrations at week 4 had another sample drawn at week 10 (68 to 72 days).
Outcome measures
| Measure |
IVIG Arm (2 gr/kg)
n=12 Participants
2nd dose of IVIG (2gr/kg)
|
Infliximab (5mg/kg)
n=12 Participants
Remicade (Infliximab Arm of 5mg/kg)
|
|---|---|---|
|
Area Under the Curve of Infliximab Concentration Before Infliximab Infusion and Then 2 and 24 Hours, 1 Week (5 to 9 Days), 2 Weeks (12 to 16 Days), and 4 Weeks (26 to 30 Days) After Infliximab Infusion)
|
0 micogram*day/ml
Interval 0.0 to 0.0
|
619 micogram*day/ml
Interval 458.0 to 891.0
|
Adverse Events
IVIG Arm (2 gr/kg)
Infliximab (5mg/kg)
Serious adverse events
| Measure |
IVIG Arm (2 gr/kg)
n=12 participants at risk
2nd dose of IVIG (2gr/kg)
|
Infliximab (5mg/kg)
n=12 participants at risk
Remicade (Infliximab Arm of 5mg/kg)
|
|---|---|---|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Enlarging aneurysms
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Persistent Fever
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
Other adverse events
| Measure |
IVIG Arm (2 gr/kg)
n=12 participants at risk
2nd dose of IVIG (2gr/kg)
|
Infliximab (5mg/kg)
n=12 participants at risk
Remicade (Infliximab Arm of 5mg/kg)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Acute gastroentiritis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Allergic rash
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Ankle pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Bee sting
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Eye disorders
Conjunctival injection
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Coronary artery aneurysm
|
8.3%
1/12 • Number of events 1
|
25.0%
3/12 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
2/12 • Number of events 2
|
33.3%
4/12 • Number of events 4
|
|
Eye disorders
Eye pain
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Cardiac disorders
Heart murmur
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Hepatobiliary disorders
Hepatomegaly
|
25.0%
3/12 • Number of events 3
|
25.0%
3/12 • Number of events 3
|
|
General disorders
High pitched crying
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Hoarseness
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
IV infiltrate
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Interval increase in size of coronary artery
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Irregular heart rate
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Lip laceration from accidental trauma
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltrate
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Pain
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Peeling of fingers and toes
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Peeling of hands
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Phimosis with swelling of foreskin
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
4/12 • Number of events 4
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Steven's Johnson Syndrome
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Teary eyes
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Temperature of 99.5 F
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
vomiting
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
Additional Information
Jane Burns, MD, Professor
University of California, San Diego
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place