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CAPE

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

    Status Not yet recruiting
    Related Conditions

Enrollment Details

1300 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Observational

This is a type IV phase trial.

Protocol ID
P11-292

Brief summary

Top

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.

Participant Attributes :
  • Male and Female
  • Ages 6 Years to 30 Years
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Study Design

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Observational Model

    Cohort

  • The relationship between the observation period and the time of patient enrollment. Time perspective can be prospective: looking forward using periodic observations usually collected following patient enrollment, or retrospective: looking back using observations usually collected prior to patient selection and enrollment.
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    Time Perspective

    Prospective

    • 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.
    • 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.

More on this trial

Clinical Trials.gov