CAPE

A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of an Active Drug in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)

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

Status:
Active, not recruiting
Conditions:
Crohn's Disease
Enrollment:
1446 patients
Protocol ID:
P11-292
Observational model:
Cohort
Time perspective:
Prospective

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Eligibility criteria

Participant attributes:
Male and Female

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.

All the cities where the clinical studies are located

Edmonton - T6G 1C9
Halifax - B3K 6R8
London - N6A 5K8
Toronto - M5G 1X8
Winnipeg - R3E 3P4

Alberta

Manitoba

Nova Scotia