A Long-Term, Non-Interventional Registry to Assess Safety and Effectiveness of Humira (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease (CD)-CAPE
Location(s): United States
The purpose of this study is to collect long-term safety and effectiveness information on Crohn’s disease or CD and the medications you are receiving as a result of your CD, such as HUMIRA® or immunosuppressant therapy without biologics (drugs that are not chemically made, but derived from living organisms). CD is known to cause inflammation and ulceration (open sore) of the small and/or large intestines. This registry study only involves the collection and storage of data related to your health status and medications/treatments. It does not involve drug testing. You may be either enrolled into the HUMIRA® group or the reference group (immunosuppressant therapy without biologics) depending on what medication you are on.
Participation in this study will last approximately 10 years or 120 months from the time you enroll. Your data will be collected at the time of enrollment in the registry, then 3 times during the first year after enrollment, and then 2 times each year from Year 2 to Year 5, and once per year from Year 6 to Year 10. During your entire study participation, there may be up to 17 time points at which data will be collected from you. Study-related procedures, such as the questionnaires, will be completed for up to 12 of these time points (the first 5 years of the study). You will not need to come to the study site solely for the purpose of the study. Data will be collected during your regular medical standard of care visits. Medical information related to safety events (e.g. hospitalization) that may occur during your 10-year participation will also be collected.
Eligibility: You must be between the ages of 6 and 17 years, diagnosed with moderately to severely active CD, and already prescribed HUMIRA® therapy according to routine clinical practice, or immunosuppressant therapy (azathioprine, 6-mercaptopurine, or methotrexate).