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CAPE


Title A Long-Term Non-Invasive Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Pediatric Patients with Moderately to Severly Active Crohn’s Disease
Therapeutic Area Crohn's Disease (Floating)
Principal Investigator Jyoti Ramakrishna, MD
Min Age 6 Years
Max Age 17 Years
Gender Both
Contact Su Mon Thwe, MD
617-636-9897
More Information https://clinicaltrials.gov/ct2/show/NCT02130362

Overview

To find out more about children with Crohn’s Disease (CD) to help doctors improve the care of patients with this disease.

Study Details

Inclusion Criteria

  • Patient that has received at least 12 weeks of immunosuppressant therapy prior to registry entry.
  • Parent/guardian hasa voluntarily signed and dated the ICF after the nature of the registry has been explained.

Exclusion Criteria

  • Patients should not be enrolled into the Humira therapy group if they are currently being treated with any investigational agents or are using any investigational procedures.
  • Patients should not be enrolled into the immunosuppressant group if they require ongoing treatment with approved biologics including Humira.

Study Requirements

This is a 10 year study. Patients will be seen every 6 moths during their regularly scheduled visits. There are no blood collections, x rays, CT scans, or MRI’s required.