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)
- Conditions
- Crohn's Disease
- Registration Number
- NCT02130362
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1446
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of treatment-emergent other AESI per 100 PYs Up to 5 years Number of treatment-emergent AESI per 100 PYs of infections and malignancies Up to 10 years Number of treatment-emergent SAEs per 100 patient years (PYs) Up to 10 years Percentage of subjects with AESI of infections, malignancies, and pregnancies Up to 10 years Percentage of subjects with SAEs Up to 10 years Number of subjects with other AESI Up to 5 years Number of subjects with AESIs other than infections and malignancies
Percentage of subjects with other AESI Up to 5 years Percentages of subjects with AESIs other than infections and malignancies
Number of subjects with Serious Adverse Events (SAEs) Up to 10 years Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies Up to 10 years
- Secondary Outcome Measures
Name Time Method Short Pediatric Crohn's Disease Activity Index (sh-PCDAI) Up to 5 years Patient completed questionnaires
IMPACT III Up to 5 years Completed by patients ages 10 through 17 years old
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
Trial Locations
- Locations (148)
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
Scroll for more (138 remaining)Univ Alabama, Birmingham CCC /ID# 146060🇺🇸Birmingham, Alabama, United States