Summary

for people ages 6-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.

Official Title

A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) - CAPE

Keywords

Crohn's Disease Registry Adalimumab Crohn's Inflammatory Bowel Diseases Gastrointestinal Diseases Crohn Disease Immunosuppressive Agents Immunosuppressant Therapy

Eligibility

You can join if…

Open to people ages 6-17

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Univ California, San Francisco /ID# 141312
    San Francisco California 94143-2204 United States
  • Childrens Hospital LA /ID# 141551
    Los Angeles California 90027 United States
  • Rabizadeh, MD, Los Angeles, CA /ID# 137269
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
http://www.rxabbvie.com/
ID
NCT02130362
Study Type
Observational
Last Updated
September 13, 2018