Last updated on October 2017

A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease


Brief description of study

The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is similar to that observed in adults with moderately to severely active Crohn's disease (CD). Also to assess the safety, immunogenicity and efficacy of ustekinumab in the treatment of moderately to severely active CD. The main part of the study continues to Week 16, at which point all subjects who are receiving benefit from ustekinumab maintenance therapy (as determined by the investigator) are eligible to enter the long-term extension (LTE) and continue to receive ustekinumab. The study extension ends at Week 236.

Clinical Study Identifier: NCT02968108

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Phoenix Children's Hospital
Phoenix, AZ United States
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Cedars-Sinai Medical Center
Los Angeles, CA United States
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Connecticut Childrens Medical Center
Hartford, CT United States
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Emory University
Atlanta, GA United States
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Children's Center For Digestive Healthcare, Llc
Atlanta, GA United States
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Methodist Medical Center of Illinois
Peoria, IL United States
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Mayo Clinic
Rochester, MN United States
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Mount Sinai
New York, NY United States
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Childrens Hospital Of Philadelphia
Philadelphia, PA United States
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Center For Digestive Health Systems-Greenville
Greenville, SC United States
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Medical College Of Wisconsin
Milwaukee, WI United States
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Universitair Kinderziekenhuis Koningin Fabiola
Brussel, Belgium
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Cliniques Universitaires Saint-Luc
Brussel, Belgium
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UZ Gent
Gent, Belgium
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UZ Brussel
Jette, Belgium
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UZ Leuven
Leuven, Belgium
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Stollery Children's Hospital
Edmonton, AB Canada
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British Columbia Children's Hospital
Vancouver, BC Canada
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Children's Hospital of Western Ontario
London, ON Canada
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Hospital For Sick Children
Toronto, ON Canada
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Centre Hospitalier Sainte Justine
Montreal, QC Canada
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H pital Jeanne de FLANDRE, CHRU LILLE
Lille, France
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H pital Necker
Paris, France
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H pital Robert Debr
Paris, France
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Klinik f r Kinder-und Jugendmedizin der Ruhr-Uni-Bochum im St. Josef-Hospital
Bochum, Germany
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Dr. von Haunersches Kinderspital
Munich, Germany
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HELIOS Klinikum Wuppertal GmbH
Wuppertal, Germany
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Instytut Centrum Zdrowia Matki Polki
Lodz, Poland
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Gabinet Lekarski Bartosz Korczowski
Rzeszow, Poland
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Centrum Zdrowia Matki, Dziecka i M odzie y
Warszawa, Poland
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II Katedra i Klinika Pediatrii Gastroenterologii i Zywienia, Uniwersytet Medyczny we Wroc awiu
Wroclaw, Poland
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