* A Long-Term, Non-Interventional Registry to Assess Safety and Effectiveness of Humira(RegisteredTM) (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn[Single Quote]s Disease (CD) – CAPE[Double Quote]

Study ID
STU 052015-012

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Sally Brinkman
214/456-0650
Sally.Brinkman@childrens.com

Principal Investigator
Ashish Patel, M.D.

Summary

This is a global, multicenter, non-interventional registry of pediatric patients with moderately to severely active CD treated in a routine clinical setting with Humira or immunosuppressant non-biologic therapy. Patients meeting entry criteria will be enrolled. all patients who consent to take part in the registry will be followed for up to 10 years, providing long-term safety and effectiveness data on Humira or immunosuppressant non-biologic therapy.

Participant Eligibility

1. 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 local approved Humira product label and meets one of the following criteria:

* Newly prescribed Humira therapy (within 4 weeks of registry entry).

* Initiated Humira therapy in the past.

* Has received continuous Humira therapy (no more than 70 consecutive days off drug) where the Investigator can provide source documentation of SAEs, Adverse Events of Special Interest (AESI) and dosing information since initiation of therapy.
OR

* Is entering after participation in an AbbVie-sponsored investigational pediatric CD trial even if >= 18 years of age, and has received continuous Humira therapy (no more than 70 consecutive days off drug).

2. 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 and meets the following criteria:

* Initiated immunosuppressant therapy in the past and:

* Has received at least 12 weeks of immunosuppressant therapy prior to registry entry where the Investigator can provide source documentation of SAEs, AESI and dosing information since initiation of therapy.
3. 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/informed consent form 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. Pediatric patients will be included in all discussions in order to obtain verbal or written assent according to applicable local regulations.