Crohn's Disease
Conditions
Keywords
Crohn's Disease, Registry, Adalimumab, Crohn's, Inflammatory Bowel Diseases, Gastrointestinal Diseases
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with AESI of infections, malignancies, and pregnancies | Up to 10 years | — |
| Percentage of subjects with other AESI | Up to 5 years | Percentages of subjects with AESIs other than infections and malignancies |
| 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 | Up to 5 years | Number of subjects with AESIs other than infections and malignancies |
| 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 | — |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) | Up to 5 years | Completed by the patients who are 18 years of age or older |
| Work Productivity and Activity Impairment (WPAI) questionnaire | Up to 5 years | Completed by caregiver up to the age of 17 years and completed by the patients of age 18 years or above. |
| Physician's Global Assessment of Disease Activity (PGA) | Up to 5 years | Completed by the physician |
| IMPACT III | Up to 5 years | Completed by patients ages 10 through 17 years old |
| Short Pediatric Crohn's Disease Activity Index (sh-PCDAI) | Up to 5 years | Patient completed questionnaires |
Countries
Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Netherlands, Portugal, Puerto Rico, Romania, Spain, Sweden, United Kingdom, United States
Outcome results
None listed