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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Crohn's Disease

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunosuppressant Therapy<br>Pediatric patients who are being prescribed and treated with immunosuppressant therapy | |
| Adalimumab (Humira) Treatment<br>Pediatric patients who are prescribed and treated with adalimumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment-emergent AESI per 100 PYs of infections and malignancies |  | Up to 10 years | 
| Percentage of subjects with SAEs |  | Up to 10 years | 
| Number of treatment-emergent other AESI per 100 PYs |  | Up to 5 years | 
| Percentage of subjects with other AESI | Percentages of subjects with AESIs other than infections and malignancies | Up to 5 years | 
| Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies |  | Up to 10 years | 
| Number of subjects with other AESI | Number of subjects with AESIs other than infections and malignancies | Up to 5 years | 
| Number of treatment-emergent SAEs per 100 patient years (PYs) |  | Up to 10 years | 
| Number of subjects with Serious Adverse Events (SAEs) |  | Up to 10 years | 
| Percentage of subjects with AESI of infections, malignancies, and pregnancies |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Pediatric Crohn's Disease Activity Index (sh-PCDAI) | Patient completed questionnaires | Up to 5 years | 
| Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) | Completed by the patients who are 18 years of age or older | Up to 5 years | 
| Work Productivity and Activity Impairment (WPAI) questionnaire | Completed by caregiver up to the age of 17 years and completed by the patients of age 18 years or above. | Up to 5 years | 
| Physician's Global Assessment of Disease Activity (PGA) | Completed by the physician | Up to 5 years | 
| IMPACT III | Completed by patients ages 10 through 17 years old | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Registry, Adalimumab, Crohn's, Inflammatory Bowel Diseases, Gastrointestinal Diseases