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: | Active, not recruiting |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 6 - 17 |
Updated: | 3/7/2019 |
Start Date: | August 28, 2014 |
End Date: | March 2, 2028 |
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
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.
pediatric patients with moderately to severely active CD who are treated as recommended in
the local product label.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
46
sites
315 Martin Luther King Jr Way
Tacoma, Washington 98405
Tacoma, Washington 98405
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
Stony Brook, New York 11794
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