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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

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.

Condition or disease
Crohn's Disease

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Study Type : Observational
Actual Enrollment : 1434 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

Group/Cohort
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



Primary Outcome Measures :
  1. Number of treatment-emergent AESI per 100 PYs of infections and malignancies [ Time Frame: Up to 10 years ]
  2. Percentage of subjects with SAEs [ Time Frame: Up to 10 years ]
  3. Number of treatment-emergent other AESI per 100 PYs [ Time Frame: Up to 5 years ]
  4. Percentage of subjects with other AESI [ Time Frame: Up to 5 years ]
    Percentages of subjects with AESIs other than infections and malignancies

  5. Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies [ Time Frame: Up to 10 years ]
  6. Number of subjects with other AESI [ Time Frame: Up to 5 years ]
    Number of subjects with AESIs other than infections and malignancies

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

Secondary Outcome Measures :
  1. Short Pediatric Crohn's Disease Activity Index (sh-PCDAI) [ Time Frame: Up to 5 years ]
    Patient completed questionnaires

  2. 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

  3. 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.

  4. Physician's Global Assessment of Disease Activity (PGA) [ Time Frame: Up to 5 years ]
    Completed by the physician

  5. IMPACT III [ Time Frame: Up to 5 years ]
    Completed by patients ages 10 through 17 years old



Information from the National Library of Medicine

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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
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.
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.

Information from the National Library of Medicine

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


Locations
Show Show 143 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02130362    
Other Study ID Numbers: P11-292
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbbVie:
Crohn's Disease
Registry
Adalimumab
Crohn's
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents