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.
Study Type
OBSERVATIONAL
Enrollment
1,446
Number of treatment-emergent AESI per 100 PYs of infections and malignancies
Time frame: Up to 10 years
Percentage of subjects with SAEs
Time frame: Up to 10 years
Number of treatment-emergent other AESI per 100 PYs
Time frame: Up to 5 years
Percentage of subjects with other AESI
Percentages of subjects with AESIs other than infections and malignancies
Time frame: Up to 5 years
Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies
Time frame: Up to 10 years
Number of subjects with other AESI
Number of subjects with AESIs other than infections and malignancies
Time frame: Up to 5 years
Number of treatment-emergent SAEs per 100 patient years (PYs)
Time frame: Up to 10 years
Number of subjects with Serious Adverse Events (SAEs)
Time frame: Up to 10 years
Percentage of subjects with AESI of infections, malignancies, and pregnancies
Time frame: Up to 10 years
Short Pediatric Crohn's Disease Activity Index (sh-PCDAI)
Patient completed questionnaires
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Univ Alabama, Birmingham CCC /ID# 146060
Birmingham, Alabama, United States
University of South Alabama /ID# 137255
Mobile, Alabama, United States
Phoenix Children's Hospital /ID# 141336
Phoenix, Arizona, United States
Children's Hospital Los Angeles /ID# 141551
Los Angeles, California, United States
Private practice: Dr. Shervin Rabizadeh /ID# 137269
Los Angeles, California, United States
Rady Children's Hospital San Diego /ID# 140883
San Diego, California, United States
Univ California, San Francisco /ID# 141312
San Francisco, California, United States
Children's Hospital Colorado - Aurora /ID# 137261
Aurora, Colorado, United States
Connecticut Children's Medical Center - Hartford /ID# 137265
Hartford, Connecticut, United States
Yale University School of Medicine /ID# 137257
New Haven, Connecticut, United States
...and 138 more locations
Time frame: 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
Time frame: 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.
Time frame: Up to 5 years
Physician's Global Assessment of Disease Activity (PGA)
Completed by the physician
Time frame: Up to 5 years
IMPACT III
Completed by patients ages 10 through 17 years old
Time frame: Up to 5 years