NCT02298062

Brief Summary

The objective of this study is to investigate the effect of infliximab to the children who don't respond to the first dose of intravenous immunoglobulin (IVIG) (2g/kg) in Kawasaki disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 3, 2016

Status Verified

December 1, 2014

Enrollment Period

2.5 years

First QC Date

September 23, 2014

Last Update Submit

February 2, 2016

Conditions

Kawasaki Disease

Keywords

Kawasaki disease coronary artery lesion, IVIG- resistant, Infliximab

Outcome Measures

Primary Outcomes (1)

  • change in concentrations of cytokines

    we will obtain laboratory data including concentrations of C-reactive protein, alanine transaminase,IL-1,IL-6,TNF-a,STNFR-I,STNFR-2 at baseline, 72 h after completion of the intravenous immunoglobulin infusion, and at week 2 and week 4 after randomisation.

    2 years

Secondary Outcomes (1)

  • incidence of coronary artery lesions(CAL)

    2 years

Study Arms (2)

Infliximab

EXPERIMENTAL

For one group of patients with resistance to intravenous immunoglobulin in Kawasaki disease , we will give them infliximab (5mg/kg) once.

Drug: Infliximab

IVIG

ACTIVE COMPARATOR

For the other group of patients with resistance to intravenous immunoglobulin in Kawasaki disease , we will give them IVIG (2g/kg) once.

Drug: IVIG

Interventions

InfliximabDRUG

The treatment-resistant children will be randomly assigned to either the infliximab or IVIG group in a 1:1 ratio and receive either infliximab (5 mg/kg at 1 mg/mL intravenously over 2 h) or IVIG (2g/kg). The primary outcome measure is change in absolute cell counts, concentrations of C-reactive protein, alanine transaminase,IL-1,IL-6,TNF-a,STNFR-I,STNFR-2; number of fever days (24 h period with a temperature of at least 38•0°C) from enrolment; duration and cost of hospital stay.The secondary 0utcome Measure is the incidence of coronary artery abnormalities

Infliximab
IVIGDRUG

The treatment-resistant children will be randomly assigned to either the infliximab or IVIG group in a 1:1 ratio and receive either infliximab (5 mg/kg at 1 mg/mL intravenously over 2 h) or IVIG (2g/kg). The primary outcome measure is change in absolute cell counts, concentrations of C-reactive protein, alanine transaminase,IL-1,IL-6,TNF-a,STNFR-I,STNFR-2; number of fever days (24 h period with a temperature of at least 38•0°C) from enrolment; duration and cost of hospital stay.The secondary 0utcome Measure is the incidence of coronary artery abnormalities

IVIG

Eligibility Criteria

Age2 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • (1)Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002.(2) Resistance to intravenous immunoglobulin in Kawasaki disease is defined as a temperature of 38.0°C or higher at 36 hours to 7 days after completion of the routine primary treatment .(3) the patients aged from 2 months to 12 years old. (4) All included patients required to sign an informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

InfliximabImmunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsImmunoglobulin GImmunoglobulin Isotypes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2014

First Posted

November 21, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

February 3, 2016

Record last verified: 2014-12

Locations

CN(1)