CAPE
Brief summary
This is a registry study to evaluate the long-term safety and effectiveness of an active drug in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.
Observational study
Age:
From 6 Years to 17 Years.
Inclusion Criteria:
- For a patient enrolling into the HUMIRA treatment group; A pediatric patient between
the ages of 6 and 17 years inclusive at the time of enrollment, diagnosed with
moderately to severely active CD who has been prescribed Humira therapy according to
the routine clinical practice.
- For a patient enrolling into the immunosuppressant therapy treatment group; A
pediatric patient between the ages of 6 and 17 years inclusive at the time of
enrollment, diagnosed with moderately to severely active CD who has been prescribed
azathioprine, 6-mercaptopurine or methotrexate.
- Parent or guardian; or patient (if 18 years of age or older at enrollment and
rolling over from an AbbVie-sponsored investigational Pediatric CD investigation
trial) has voluntarily signed and dated an Authorization for Use/Disclosure of Data
(AUDD)/informed consent form (ICF) after the nature of the registry has been
explained and the patient, patient's parent or legal guardian has had the
opportunity to ask questions.
Exclusion Criteria:
- Patients should not be enrolled into the registry if they are currently being
treated with any investigational agents or are receiving any investigational
procedures.
- Patients should not be enrolled into the immunosuppressant therapy treatment group
if they require ongoing treatment with approved biologic agents including HUMIRA.
