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) (CAPE)

• ClinicalTrials.gov Identifier: NCT02130362
• Recruitment Status: Active, not recruiting
• First Posted: May 5, 2014
• Last Update Posted: June 9, 2022
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: May 1, 2014
• First Posted Date: May 5, 2014
• Last Update Posted Date: June 9, 2022
• Actual Study Start Date: August 28, 2014
• Estimated Primary Completion Date: March 2, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2018)

• 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 [ Time Frame: 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 [ 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
• 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 ]

Original Primary Outcome Measures (submitted: May 1, 2014)

• Number of subjects with Serious Adverse Events (SAEs) [ Time Frame: Up to 10 years ]
• Percentage of subjects with 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 ]
• Percentage of subjects with AESI of infections, malignancies, and pregnancies [ 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 treatment-emergent SAEs per 100 patient years (PYs) [ Time Frame: Up to 10 years ]
• Number of treatment-emergent AESI per 100 PYs of infections and malignancies [ Time Frame: Up to 10 years ]
• Number of treatment-emergent other AESI per 100 PYs [ Time Frame: Up to 5 years ]

Current Secondary Outcome Measures (submitted: September 13, 2018)

• Short Pediatric Crohn's Disease Activity Index (sh-PCDAI) [ Time Frame: Up to 5 years ]
  Patient completed questionnaires
• Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: Up to 5 years ]
  Completed by the patients who are 18 years of age or older
• Work Productivity and Activity Impairment (WPAI) questionnaire [ Time Frame: 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) [ Time Frame: Up to 5 years ]
  Completed by the physician
• IMPACT III [ Time Frame: Up to 5 years ]
  Completed by patients ages 10 through 17 years old

Original Secondary Outcome Measures (submitted: May 1, 2014)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• Official Title: 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
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Pediatric patients with moderately to severely active Crohn's Disease (CD) who have been prescribed HUMIRA according to the local label and pediatric patients being prescribed and treated with IMM (azathioprine, 6-mercaptopurine, or methotrexate). Patients being prescribed and treated with immunosuppressant therapy with no concurrent biologic use will be enrolled as a reference group.
• Condition: Crohn's Disease
• Intervention: Not Provided

Study Groups/Cohorts

• Immunosuppressant Therapy
  Pediatric patients who are being prescribed and treated with immunosuppressant therapy
• Adalimumab (Humira) Treatment
  Pediatric patients who are prescribed and treated with adalimumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 17, 2020): 1446
• Original Estimated Enrollment (submitted: May 1, 2014): 1300
• Estimated Study Completion Date: March 2, 2028
• Estimated Primary Completion Date: March 2, 2028 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location 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
• Removed Location Countries: Australia, Czech Republic, Hungary, Poland, Slovenia

Administrative Information

• NCT Number: NCT02130362
• Other Study ID Numbers: P11-292
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: June 2022