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 : June 9, 2022
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|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1446 participants|
|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|
|Actual Study Start Date :||August 28, 2014|
|Estimated Primary Completion Date :||March 2, 2028|
|Estimated Study Completion Date :||March 2, 2028|
Pediatric patients who are being prescribed and treated with immunosuppressant therapy
Adalimumab (Humira) Treatment
Pediatric patients who are prescribed and treated with adalimumab
- 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 ]
- 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
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|Ages Eligible for Study:||6 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130362
|Study Director:||ABBVIE INC.||AbbVie|
|Other Study ID Numbers:||
|First Posted:||May 5, 2014 Key Record Dates|
|Last Update Posted:||June 9, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|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|
Inflammatory Bowel Diseases
Inflammatory Bowel Diseases
Digestive System Diseases