Trial Outcomes & Findings for Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease (NCT NCT00760435)
NCT ID: NCT00760435
Last Updated: 2014-11-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
196 participants
Primary outcome timeframe
10 weeks
Results posted on
2014-11-24
Participant Flow
Participant milestones
| Measure |
Infliximab Arm
98 recieved infliximab plus IVIG
Infliximab: 5 mg/kg IV over 2 hours once
|
Placebo Arm
98 received Placebo plus IVIG
Placebo: Placebo (same volume as active drug)
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
98
|
|
Overall Study
COMPLETED
|
94
|
93
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease
Baseline characteristics by cohort
| Measure |
Infliximab Arm
n=98 Participants
98 recieved infliximab plus IVIG
Infliximab: 5 mg/kg IV over 2 hours once
|
Placebo Arm
n=98 Participants
98 received Placebo plus IVIG
Placebo: Placebo (same volume as active drug)
|
Total
n=196 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
3.0 years
n=5 Participants
|
2.8 years
n=7 Participants
|
2.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
57 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
98 participants
n=7 Participants
|
196 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: 1 subject in the placebo group was removed from the modified ITT analysis (this subject was removed from the study prior to receiving the placebo)
Outcome measures
| Measure |
Infliximab
n=98 Participants
98 subjects treated with infliximab + IVIG
|
Placebo
n=97 Participants
97 subjects who received placebo + IVIG
|
|---|---|---|
|
The Number of Subjects in Each Arm That Have Persistent or Recrudescent Fever 24 Hours After Completion of the Intravenous Immunoglobulin (IVIG) Infusion
|
11 participants
|
11 participants
|
SECONDARY outcome
Timeframe: up to 6 weeksOutcome measures
| Measure |
Infliximab
n=98 Participants
98 subjects treated with infliximab + IVIG
|
Placebo
n=97 Participants
97 subjects who received placebo + IVIG
|
|---|---|---|
|
Number of Days of Fever Following Therapy During Study Period (up to 6 Weeks)
|
1 days
Interval 1.0 to 2.0
|
2 days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Infliximab
n=98 Participants
98 subjects treated with infliximab + IVIG
|
Placebo
n=97 Participants
97 subjects who received placebo + IVIG
|
|---|---|---|
|
Change in C-reactive Protein (CRP) From Baseline at 24 Hours After Completion of Intravenous Immunoglobulin (IVIG) by Study Arm.
|
-6.6 mg/dL
Interval -7.7 to -5.4
|
-3.6 mg/dL
Interval -4.8 to -2.5
|
SECONDARY outcome
Timeframe: 2 weeksleft anterior descending coronary artery Z-score; a Z score is the coronary artery adjusted for body surface area
Outcome measures
| Measure |
Infliximab
n=98 Participants
98 subjects treated with infliximab + IVIG
|
Placebo
n=97 Participants
97 subjects who received placebo + IVIG
|
|---|---|---|
|
Change From Baseline in Left Anterior Descending Coronary Artery Outcomes at Week 2 by Treatment Arm
|
-0.605 Z-score
Interval -0.808 to -0.403
|
-0.313 Z-score
Interval -0.514 to -0.111
|
Adverse Events
Infliximab Arm
Serious events: 22 serious events
Other events: 49 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 17 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infliximab Arm
n=98 participants at risk
98 recieved infliximab plus IVIG
Infliximab: 5 mg/kg IV over 2 hours once
|
Placebo Arm
n=98 participants at risk
98 received Placebo plus IVIG
Placebo: Placebo (same volume as active drug)
|
|---|---|---|
|
Immune system disorders
Fever
|
11.2%
11/98 • Number of events 11 • 10 weeks
|
11.3%
11/97 • Number of events 11 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.0%
1/98 • Number of events 1 • 10 weeks
|
1.0%
1/98 • Number of events 1 • 10 weeks
|
|
Cardiac disorders
Coronary artery abnormality
|
6.1%
6/98 • Number of events 6 • 10 weeks
|
2.0%
2/98 • Number of events 2 • 10 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
1.0%
1/98 • Number of events 1 • 10 weeks
|
1.0%
1/98 • Number of events 1 • 10 weeks
|
|
Immune system disorders
Macrophage Activation Syndrome
|
0.00%
0/98 • 10 weeks
|
1.0%
1/98 • Number of events 1 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.00%
0/98 • 10 weeks
|
1.0%
1/98 • Number of events 1 • 10 weeks
|
|
Nervous system disorders
Headache
|
2.0%
2/98 • Number of events 2 • 10 weeks
|
1.0%
1/98 • Number of events 1 • 10 weeks
|
|
Infections and infestations
URI
|
2.0%
2/98 • Number of events 2 • 10 weeks
|
0.00%
0/98 • 10 weeks
|
Other adverse events
| Measure |
Infliximab Arm
n=98 participants at risk
98 recieved infliximab plus IVIG
Infliximab: 5 mg/kg IV over 2 hours once
|
Placebo Arm
n=98 participants at risk
98 received Placebo plus IVIG
Placebo: Placebo (same volume as active drug)
|
|---|---|---|
|
Immune system disorders
IVIG Infusion Reaction
|
0.00%
0/98 • 10 weeks
|
13.3%
13/98 • Number of events 13 • 10 weeks
|
|
Cardiac disorders
Coronary artery abnormality
|
5.1%
5/98 • Number of events 5 • 10 weeks
|
11.2%
11/98 • Number of events 11 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
6/98 • Number of events 6 • 10 weeks
|
10.2%
10/98 • Number of events 10 • 10 weeks
|
|
Infections and infestations
URI
|
16.3%
16/98 • Number of events 16 • 10 weeks
|
19.4%
19/98 • Number of events 19 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
7/98 • Number of events 7 • 10 weeks
|
7.1%
7/98 • Number of events 7 • 10 weeks
|
|
Gastrointestinal disorders
Vomiting/nausea/abdominal pain
|
9.2%
9/98 • Number of events 9 • 10 weeks
|
17.3%
17/98 • Number of events 17 • 10 weeks
|
|
Blood and lymphatic system disorders
Worsening of WBC
|
10.2%
10/98 • Number of events 10 • 10 weeks
|
13.3%
13/98 • Number of events 13 • 10 weeks
|
Additional Information
Dr. Adriana H. Tremoulet
University of California, San Diego
Phone: 858-246-0012
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place