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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02130362
Recruitment Status : Active, not recruiting
First Posted : May 5, 2014
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date May 1, 2014
First Posted Date May 5, 2014
Last Update Posted Date March 5, 2019
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 ]
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 13, 2018)
1434
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
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date March 2019