A Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients with Moderately to Severely Active Crohn's Disease

Overview

About this study

The purpose of this study is to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active crohn's disease

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • For the HUMIRA treatment group
    • Children between the ages of 6 and 17 years inclusive at the time of enrollment
    • Diagnosed with moderately to severely active Crohn's Disease
    • Has been prescribed Humira therapy according to the local approved Humira product label
  • For the immunosuppressant therapy treatment group
    • Children between the ages of 6 and 17 years inclusive at the time of enrollment
    • Diagnosed with moderately to severely active Crohn's Disease
    • 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 Crohn's Disease 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 there has been the opportunity to ask questions

Exclusion Criteria

  • Cannot be treated in accordance with the local Humira product label
  • Is currently being treated with any investigational agents or is receiving any investigational procedures
  • Should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including HUMIRA

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Faubion, M.D.

Closed for enrollment

Contact information:

Janell Ellenbecker

(507) 284-0523

Ellenbecker.Janell@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20272694

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