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

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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.


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
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Atlanta, Georgia 30322
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Birmingham, Alabama 35294
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Boston, Massachusetts 02111
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Boston, Massachusetts 02114
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300 Longwood Avenue
Boston, Massachusetts 02115
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Buffalo, New York 14222
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Burlington, Vermont 05405
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Chapel Hill, North Carolina 27514
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Charleston, South Carolina 29425
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100 North Academy Avenue
Danville, Pennsylvania 17822
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Durham, North Carolina 27710
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Fairfax, Virginia 22031
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Hartford, Connecticut 06106
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Hershey, Pennsylvania 17033
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Jackson, Mississippi 39216
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Jacksonville, Florida 32207
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Los Angeles, California 90027
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Los Angeles, California 90048
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Miami, Florida 33136
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Minneapolis, Minnesota 55455
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1707 Center Street
Mobile, Alabama 36604
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Morristown, New Jersey 07962
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New Haven, Connecticut 06510
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New Hyde Park, New York 11040
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New Orleans, Louisiana 70118
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New York, New York 10032
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1200 Childrens Avenue
Oklahoma City, Oklahoma 73104
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Portland, Maine 04102
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3020 Children's Way
San Diego, California 92123
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550 16th Street
San Francisco, California 94158
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1221 Madison Street
Seattle, Washington 98104
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4800 Sand Point Way Northeast
Seattle, Washington 98105
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3 Edmund D. Pellegrino Road
Stony Brook, New York 11794
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750 East Adams Street
Syracuse, New York 13210
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315 Martin Luther King Jr Way
Tacoma, Washington 98405
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Tuzla,
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Worcester, Massachusetts 01655
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