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Trial record 17 of 31 for:    "Kawasaki syndrome"

Infliximab (Remicade) for Patients With Acute Kawasaki Disease

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ClinicalTrials.gov Identifier: NCT00271570
Recruitment Status : Completed
First Posted : January 2, 2006
Results First Posted : December 29, 2009
Last Update Posted : June 14, 2010
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
University of California, San Diego

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kawasaki Disease
Interventions Drug: Infliximab (Remicade)
Biological: Intravenous immunoglobulin (IVIG)
Enrollment 24

Recruitment Details  
Pre-assignment Details  
Arm/Group Title IVIG Arm (2 gr/kg) Infliximab (5mg/kg)
Hide Arm/Group Description 2nd dose of IVIG (2gr/kg) Remicade (Infliximab Arm of 5mg/kg)
Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title IVIG Arm (2 gr/kg) Infliximab (5mg/kg) Total
Hide Arm/Group Description 2nd dose of IVIG (2gr/kg) Remicade (Infliximab Arm of 5mg/kg) Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
12
 100.0%
12
 100.0%
24
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
1.833  (.3) 1.667  (.3) 1.75  (.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
3
  25.0%
4
  33.3%
7
  29.2%
Male
9
  75.0%
8
  66.7%
17
  70.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)
Hide Description 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.
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVIG Arm (2 gr/kg) Infliximab (5mg/kg)
Hide Arm/Group Description:
2nd dose of IVIG (2gr/kg)
Remicade (Infliximab Arm of 5mg/kg)
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: events
2 3
2.Primary Outcome
Title 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)
Hide Description 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).
Time Frame 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVIG Arm (2 gr/kg) Infliximab (5mg/kg)
Hide Arm/Group Description:
2nd dose of IVIG (2gr/kg)
Remicade (Infliximab Arm of 5mg/kg)
Overall Number of Participants Analyzed 12 12
Median (Inter-Quartile Range)
Unit of Measure: micogram*day/ml
0
(0 to 0)
619
(458 to 891)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IVIG Arm (2 gr/kg) Infliximab (5mg/kg)
Hide Arm/Group Description 2nd dose of IVIG (2gr/kg) Remicade (Infliximab Arm of 5mg/kg)
All-Cause Mortality
IVIG Arm (2 gr/kg) Infliximab (5mg/kg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IVIG Arm (2 gr/kg) Infliximab (5mg/kg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      3/12 (25.00%)    
Cardiac disorders     
Enlarging aneurysms  [1]  0/12 (0.00%)  0 1/12 (8.33%)  1
General disorders     
Fever  [2]  1/12 (8.33%)  1 0/12 (0.00%)  0
Persistent Fever  [3]  1/12 (8.33%)  1 0/12 (0.00%)  0
Nervous system disorders     
Cerebellar ataxia  [4]  0/12 (0.00%)  0 1/12 (8.33%)  1
Skin and subcutaneous tissue disorders     
Rash  [5]  0/12 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
[1]
Enlarging aneurysms (z-max: RCA, 7.5; LAD, 4.9); readmitted for repeat infliximab and IVIG infusion; aneurysms resolved
[2]
Persistent fever plus rising CRP treated with IV methylprednisilone; aneurysms of RCA and LAD (z-max: RCA, 7.2; LAD, 8.1)
[3]
Persistent fever treated with IV methylprednisilone, oral steroids, and methotrexate; dilated coronary arteries (z-max: RCA, 4.6; LAD, 3.3), dilatation resolved
[4]
Acute cerebellar ataxia attributed to KD (resolved); giant aneurysms (> 8 mm) treated with warfarin (z-max: RCA, 15.8; LAD, 7.44)
[5]
Drug-related rash with eosinophilia and systemic symptoms, attributed to azithromycin administered before study entry (reported to the FDA), requiring hospitalization for supportive care; normal coronary arteries
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IVIG Arm (2 gr/kg) Infliximab (5mg/kg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/12 (66.67%)      10/12 (83.33%)    
Blood and lymphatic system disorders     
Anemia   2/12 (16.67%)  2 0/12 (0.00%)  0
Cardiac disorders     
Coronary artery aneurysm   1/12 (8.33%)  1 3/12 (25.00%)  3
Heart murmur  [1]  1/12 (8.33%)  1 1/12 (8.33%)  1
Interval increase in size of coronary artery   0/12 (0.00%)  0 1/12 (8.33%)  1
Irregular heart rate   1/12 (8.33%)  1 0/12 (0.00%)  0
Pericardial effusion  [2]  0/12 (0.00%)  0 1/12 (8.33%)  1
Eye disorders     
Conjunctival injection   1/12 (8.33%)  1 0/12 (0.00%)  0
Eye pain   0/12 (0.00%)  0 1/12 (8.33%)  1
Teary eyes   1/12 (8.33%)  1 0/12 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension   1/12 (8.33%)  1 0/12 (0.00%)  0
Acute gastroentiritis  [3]  1/12 (8.33%)  1 0/12 (0.00%)  0
Constipation   1/12 (8.33%)  1 1/12 (8.33%)  1
Gastritis   1/12 (8.33%)  1 0/12 (0.00%)  0
vomiting   1/12 (8.33%)  1 0/12 (0.00%)  0
General disorders     
Bee sting   1/12 (8.33%)  1 0/12 (0.00%)  0
High pitched crying  [4]  0/12 (0.00%)  0 1/12 (8.33%)  1
Hoarseness   0/12 (0.00%)  0 1/12 (8.33%)  1
Temperature of 99.5 F   1/12 (8.33%)  1 0/12 (0.00%)  0
Hepatobiliary disorders     
Hepatomegaly   3/12 (25.00%)  3 3/12 (25.00%)  3
Musculoskeletal and connective tissue disorders     
Ankle pain   1/12 (8.33%)  1 0/12 (0.00%)  0
Nervous system disorders     
Pain   1/12 (8.33%)  1 1/12 (8.33%)  1
Renal and urinary disorders     
Hematuria   0/12 (0.00%)  0 1/12 (8.33%)  1
Phimosis with swelling of foreskin   0/12 (0.00%)  0 1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders     
Lung infiltrate   1/12 (8.33%)  1 0/12 (0.00%)  0
Nasal congestion   1/12 (8.33%)  1 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders     
Allergic rash   1/12 (8.33%)  1 0/12 (0.00%)  0
Dry skin   2/12 (16.67%)  2 4/12 (33.33%)  4
IV infiltrate   1/12 (8.33%)  1 1/12 (8.33%)  1
Lip laceration from accidental trauma   1/12 (8.33%)  1 0/12 (0.00%)  0
Peeling of fingers and toes   1/12 (8.33%)  1 1/12 (8.33%)  1
Peeling of hands   0/12 (0.00%)  0 1/12 (8.33%)  1
Rash   4/12 (33.33%)  4 1/12 (8.33%)  1
Steven's Johnson Syndrome   0/12 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
[1]
I/VI systolic ejection murmur
[2]
Trivial size
[3]
Secondary to rotavirus
[4]
Sometimes raspy voice
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jane Burns, MD, Professor
Organization: University of California, San Diego
Phone: 858-246-0155
Responsible Party: Jane C. Burns, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00271570     History of Changes
Other Study ID Numbers: 041374
2004-0548
First Submitted: December 30, 2005
First Posted: January 2, 2006
Results First Submitted: May 1, 2009
Results First Posted: December 29, 2009
Last Update Posted: June 14, 2010