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Abbott Laboratories – A Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Paediatric Subjects with Moderate to Severe Crohn’s Disease
The purpose of this study is to evaluate the safety, efficacy and dosing of Adalimumab for the treatment of moderate to severe Crohn’s disease in paediatric subjects. While Adalimumab is approved for the treatment of adult Crohn’s disease in the United States, European Union and Canada, it is still being tested for use in paediatrics.
This study is being conducted at about 55 treatment centers in the United States, Canada and Europe. Approximately 184 paediatric subjects with Crohn’s disease will participate in this study for up to 12 months and 13 weeks.
A naturally occurring substance in our immune system called the tumor necrosis factor-alpha (TNFα) is thought to play a role in creating the chronic inflammation that causes the symptoms of Crohn’s disease. Adalimumab is an antibody that has been developed to relieve the symptoms of Crohn’s disease by attaching to TNFα and thus helping control the inflammation. An antibody is a naturally occurring substance produced by the immune system. Adalimumab is made in a laboratory and is identical to a natural human antibody. Please contact your Gastroenterologist or the research coordinator for more information: Terry Viczko, RN
Research Coordinator
Division of Gastroenterology, BC Children's Hospital
Phone: 604-875-2345 ext. 5312
Email:
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