Kawasaki DiseasePhase 1NCT00271570
Infliximab (Remicade) for Patients With Acute Kawasaki Disease
A Phase 1 study testing Infliximab (Remicade) and Intravenous immunoglobulin (IVIG) in people with Kawasaki Disease, run by University of California, San Diego at 1 site in United States.
Trial summary
This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- Infliximab (Remicade) and Intravenous immunoglobulin (IVIG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Oct 2006
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- To be eligible for the trial, subjects must meet all of the following criteria:
- All eligible subjects, or legal representative, must provide written informed consent/assent, prior to initiation of any study procedure.
- 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).
- Patients must have persistent or reoccurrence of fever > 48 hours of observation to be eligible for the trial.
- 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.
- Patients must present for their initial diagnosis and IVIG treatment within the first 14 days after fever onset (Illness Day 14).
- 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.
- 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.
Who cannot join
- If a subject has any of the following criteria, he or she may not be enrolled in the study:
- Have been receiving corticosteroids (ie, via any route) at doses > 1 mg/kg prednisone equivalent daily.
- Have history of TB or TB exposure.
- Have history of histoplasmosis or coccidiomycosis.
- Have received anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®) within 1 month prior to first study drug administration.
- Have any chronic disease, except asthma, atopic dermatitis or controlled seizure disorder.
Show all 19Show fewer
- Have documented history of current active hepatitis B or a history of hepatitis C infection.
- Have documented history of human immunodeficiency virus (HIV) infection
- Have received a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to first study drug administration).
- 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).
- Have a history of prior lymphoproliferative disease including lymphoma.
- Have multiple sclerosis or other central demyelinating disorder.
- Have received any previous treatment with infliximab or other monoclonal antibodies.
- 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.
- Are participating in another investigative trial, involving investigational agents, during participation in this trial.
- Have a history of substance abuse (drug or alcohol) within the previous 3 years.
- Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
- Have a known allergy to murine proteins or other chimeric proteins.
- Patients with ischemic congestive heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infliximab (Remicade) for Patients With Acute Kawasaki Disease Who Fail to Become Afebrile After Intravenous Gamma Globulin Therapy
This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease.
Read the detailed description
This study is an exploratory, pilot study to examine tolerance and pharmacokinetics of infliximab in infants and children with acute Kawasaki Disease.
- Conditions
- Kawasaki Disease
- Being tested
- Infliximab (Remicade), Intravenous immunoglobulin (IVIG)
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab (Remicade)Drug
Remicade was 5 mg/kg IV (single dose)
Intravenous immunoglobulin (IVIG)Biological
Also called Gammagard, Gamunex
2nd dose of IVIG (2g/kg)
| Study group | Role | What they receive |
|---|---|---|
| Second Dose of IVIG (2g/kg) | Active comparator | Subjects who did not respond to the first dose of IVIG received a 2nd dose of IVIG in this arm (2g/kg) Receives: Biological: Intravenous immunoglobulin (IVIG) |
| Infliximab (5mg/kg) | Experimental | Remicade (5mg/kg) single dose Receives: Drug: Infliximab (Remicade) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)
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.
Measured: 2 weeks
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)
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2006 (estimated)
- Study startApr 2004
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor, Inc.
- Investigators
- Jane C Burns, M.D., Principal investigator, UCSD/CHHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271570
- Sponsor's protocol ID
- 041374
- Other IDs
- 2004-0548
- Status last verified
- Nov 2009
- First submitted
- 30 Dec 2005
- Last updated
- 14 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infliximab (Remicade) for Patients With Acute Kawasaki Disease Who Fail to Become Afebrile After Intravenous Gamma Globulin Therapy
- ClinicalTrials.gov ID
- NCT00271570
- Acronym / sponsor ID
- 041374
- Conditions
- Kawasaki Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Centocor, Inc.
- Study start
- Apr 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 2 Jan 2006 (estimated)
- Results
- Posted 29 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease.
Detailed description
This study is an exploratory, pilot study to examine tolerance and pharmacokinetics of infliximab in infants and children with acute Kawasaki Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second Dose of IVIG (2g/kg) | Active comparator | Biological: Intravenous immunoglobulin (IVIG)Subjects who did not respond to the first dose of IVIG received a 2nd dose of IVIG in this arm (2g/kg) |
| Infliximab (5mg/kg) | Experimental | Drug: Infliximab (Remicade)Remicade (5mg/kg) single dose |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- All eligible subjects, or legal representative, must provide written informed consent/assent, prior to initiation of any study procedure.
- 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).
- Patients must have persistent or reoccurrence of fever > 48 hours of observation to be eligible for the trial.
- 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.
- Patients must present for their initial diagnosis and IVIG treatment within the first 14 days after fever onset (Illness Day 14).
Key exclusion criteria (19 listed)
- If a subject has any of the following criteria, he or she may not be enrolled in the study:
- Have been receiving corticosteroids (ie, via any route) at doses > 1 mg/kg prednisone equivalent daily.
- Have history of TB or TB exposure.
- Have history of histoplasmosis or coccidiomycosis.
- Have received anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®) within 1 month prior to first study drug administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infliximab (Remicade)Remicade was 5 mg/kg IV (single dose) | Drug | Infliximab (5mg/kg) |
| Intravenous immunoglobulin (IVIG)Also: Gammagard, Gamunex2nd dose of IVIG (2g/kg) | Biological | Second Dose of IVIG (2g/kg) |
Primary outcome
Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration)
Time frame: 2 weeks
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.
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane C Burns, M.D. principal investigator
UCSD/CHHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Infliximab (Remicade) and Intravenous immunoglobulin (IVIG) in people with Kawasaki Disease, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (Focused on Side Effects From IVIG or Infliximab Administration) (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2010.