Infliximab (Remicade) for Patients With Acute Kawasaki Disease

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00271570
First received: December 30, 2005
Last updated: June 11, 2010
Last verified: November 2009
  Purpose

This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease.


Condition Intervention Phase
Kawasaki Disease
Drug: Infliximab (Remicade)
Biological: Intravenous immunoglobulin (IVIG)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Infliximab (Remicade) for Patients With Acute Kawasaki Disease Who Fail to Become Afebrile After Intravenous Gamma Globulin Therapy

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.

  • 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) [ 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. ] [ Designated as safety issue: No ]
    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).


Enrollment: 24
Study Start Date: April 2004
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Second Dose of IVIG (2g/kg)
Subjects who did not respond to the first dose of IVIG received a 2nd dose of IVIG in this arm (2g/kg)
Biological: Intravenous immunoglobulin (IVIG)
2nd dose of IVIG (2g/kg)
Other Name: Gammagard, Gamunex
Experimental: Infliximab (5mg/kg)
Remicade (5mg/kg) single dose
Drug: Infliximab (Remicade)
Remicade was 5 mg/kg IV (single dose)

Detailed Description:

This study is an exploratory, pilot study to examine tolerance and pharmacokinetics of infliximab in infants and children with acute Kawasaki Disease.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

To be eligible for the trial, subjects must meet all of the following criteria:

  1. All eligible subjects, or legal representative, must provide written informed consent/assent, prior to initiation of any study procedure.
  2. Eligible subjects will be infants and children, under 18 years old, with acute KD who remain or become febrile (>/= 38.3˚ C or 101.0˚ F) after the end of the 48 h-period after completing their IVIG infusion (2gm/kg).
  3. Patients must have persistent or reoccurrence of fever > 48 hours of observation to be eligible for the trial.
  4. Prior to the initial IVIG treatment, patients must have been febrile for >/= 3 days and have met 4/5 standard clinical criteria (Table 1) - OR - patients with fever and 3/5 clinical criteria will be eligible if echocardiogram demonstrates at least one coronary artery segment with a Z score of > 2.
  5. Patients must present for their initial diagnosis and IVIG treatment within the first 14 days after fever onset (Illness Day 14).
  6. Females of childbearing potential and males must be using adequate contraception (abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the trial.
  7. All eligible subjects must have a chest radiograph within one week prior to first infusion of study drug with no evidence of malignancy, infection or fibrosis.

Exclusion criteria

If a subject has any of the following criteria, he or she may not be enrolled in the study:

  1. Have been receiving corticosteroids (ie, via any route) at doses > 1 mg/kg prednisone equivalent daily.
  2. Have history of TB or TB exposure.
  3. Have history of histoplasmosis or coccidiomycosis.
  4. Have received anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®) within 1 month prior to first study drug administration.
  5. Have any chronic disease, except asthma, atopic dermatitis or controlled seizure disorder.
  6. Have documented history of current active hepatitis B or a history of hepatitis C infection.
  7. Have documented history of human immunodeficiency virus (HIV) infection
  8. Have received a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to first study drug administration).
  9. Have a known malignancy or history of malignancy within the 5-year period prior to first study drug administration (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence).
  10. Have a history of prior lymphoproliferative disease including lymphoma.
  11. Have multiple sclerosis or other central demyelinating disorder.
  12. Have received any previous treatment with infliximab or other monoclonal antibodies.
  13. Have used any investigational drug within 1 month prior to first study drug administration or within 5 half-lives of the investigational agent, whichever is longer.
  14. Are participating in another investigative trial, involving investigational agents, during participation in this trial.
  15. Have a history of substance abuse (drug or alcohol) within the previous 3 years.
  16. Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
  17. Have a known allergy to murine proteins or other chimeric proteins.
  18. Patients with ischemic congestive heart failure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271570

Locations
United States, California
Ucsd/Chhc
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Centocor, Inc.
Investigators
Principal Investigator: Jane C Burns, M.D. UCSD/CHHC
  More Information

No publications provided

Responsible Party: Jane C. Burns, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00271570     History of Changes
Other Study ID Numbers: 041374, 2004-0548
Study First Received: December 30, 2005
Results First Received: May 1, 2009
Last Updated: June 11, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Infliximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 23, 2014