This is a 5 year observational study of patients with Inflammatory Bowel Disease (IBD), which includes Crohn's disease, Ulcerative colitis and Indeterminate colitis, to learn more about people who have IBD and the medications that they take. The study includes an optional biospecimen repository to investigate viral resistance, genomics, and biomarkers, and that retrospective data on these IBD patients will be reserved.
A Crohn's Disease Registry for pediatric patients (between the ages of 6 and 17 years) with moderately to severely active Crohn's Disease (CD), who are already taking Humira® (Adalimumab) to treat their condition. Data from the participant's medical record will be collected to study the long-term safety and effectiveness of Humira®. The Registry expects to collect data for 10 years. No study drug will be given.
The purpose of this study is to evaluate the effectiveness and safety of higher induction and maintenance dosing regimens in subjects with moderately to severely active Crohn's disease.
A minimum of 1000 AA subjects with IBD will be recruited in the 4 year period; from Emory, Grady and Children's Healthcare of Atlanta. And a total of 2500 patients form the collaborating institutions.
The primary investigative design will be a paired case-control study. This study will be similar to other IRB approved protocols in which DNA, serum, are collected from children and adults with and without IBD for the purpose of genotype analysis.