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| Sponsor: | University of California, San Diego |
|---|---|
| Collaborator: |
Nationwide Children's Hospital |
| Information provided by: | University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00760435 |
Purpose
The purpose of this study is to determine whether the addition of infliximab to standard primary therapy of intravenous immunoglobulin (IVIG) and high dose aspirin will reduce resistance to therapy in acute Kawasaki disease (KD).
| Condition | Intervention | Phase |
|---|---|---|
|
Kawasaki Disease |
Drug: Infliximab Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Infliximab (Remicade®) Plus Intravenous Immunoglobulin (IVIG) for the Primary Treatment of Patients With Acute Kawasaki Disease |
| Estimated Enrollment: | 196 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Infliximab plus IVIG
|
Drug: Infliximab
5 mg/kg IV over 2 hours once
Other Name: Remicade
|
|
Placebo Comparator: 2
Placebo plus IVIG
|
Drug: Placebo
Placebo (same volume as active drug)
|
KD, an orphan disease of low prevalence in U.S. children, causes significant long term cardiac sequelae in a subset of patients. KD patients that are resistant to therapy are more likely to develop coronary artery abnormalities. This phase III placebo-controlled, multicenter, randomized clinical trial of infliximab plus standard therapy vs. placebo plus standard therapy in acute KD will determine if the addition of infliximab to primary therapy can reduce the percentage of children resistant to therapy.
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who meet one of the following sets of criteria will be eligible for enrollment (adapted from AHA guidelines: Newburger et al. 2004):
Exclusion Criteria:
Contacts and Locations| Contact: Adriana H Tremoulet, M.D. | 858-246-0012 | atremoulet@ucsd.edu |
| United States, California | |
| University of California, San Diego | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Adriana H. Tremoulet, M.D. 858-246-0012 atremoulet@ucsd.edu | |
| Contact: Joan Pancheri, R.N. 858-966-6264 jpancheri@rchsd.org | |
| Principal Investigator: Jane C. Burns, M.D. | |
| Sub-Investigator: Adriana H. Tremoulet, M.D. | |
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States | |
| Contact: Octavio Ramilo, M.D. octavio.ramilo@nationwidechildrens.org | |
| Contact: Preeti Jaggi, MD preeti.jaggi@nationwidechildrens.org | |
| Principal Investigator: Octavio Ramilo, M.D. | |
| Sub-Investigator: Preeti Jaggi, M.D. | |
| Principal Investigator: | Jane C Burns, M.D. | University of California, San Diego |
| Study Director: | Adriana H. Tremoulet, M.D. | University of California, San Diego |
| Study Director: | Octavio Ramilo, M.D. | University of Texas |
More Information
| Responsible Party: | Jane C. Burns, M.D./Professor of Pediatrics, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00760435 History of Changes |
| Other Study ID Numbers: | 1 R01 FD003514-01 |
| Study First Received: | September 25, 2008 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Kawasaki disease Infliximab Remicade Pediatrics |
|
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 |