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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Crohn's Disease
- Sponsor
- AbbVie
- Enrollment
- 1446
- Locations
- 148
- Primary Endpoint
- Number of treatment-emergent other AESI per 100 PYs
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of treatment-emergent other AESI per 100 PYs
Time Frame: Up to 5 years
Number of treatment-emergent AESI per 100 PYs of infections and malignancies
Time Frame: Up to 10 years
Number of treatment-emergent SAEs per 100 patient years (PYs)
Time Frame: Up to 10 years
Percentage of subjects with AESI of infections, malignancies, and pregnancies
Time Frame: Up to 10 years
Percentage of subjects with SAEs
Time Frame: Up to 10 years
Number of subjects with other AESI
Time Frame: Up to 5 years
Number of subjects with AESIs other than infections and malignancies
Percentage of subjects with other AESI
Time Frame: Up to 5 years
Percentages of subjects with AESIs other than infections and malignancies
Number of subjects with Serious Adverse Events (SAEs)
Time Frame: Up to 10 years
Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies
Time Frame: Up to 10 years
Secondary Outcomes
- Short Pediatric Crohn's Disease Activity Index (sh-PCDAI)(Up to 5 years)
- IMPACT III(Up to 5 years)
- Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ)(Up to 5 years)
- Work Productivity and Activity Impairment (WPAI) questionnaire(Up to 5 years)
- Physician's Global Assessment of Disease Activity (PGA)(Up to 5 years)