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Trial record 2 of 3 for:    HN registry

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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02130362
First received: May 1, 2014
Last updated: January 26, 2015
Last verified: January 2015
  Purpose

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 product label.


Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) - CAPE

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number of subjects with Serious Adverse Events (SAEs) [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with SAEs [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • Number of subjects with Adverse Events of Special Interest (AESI) of infections, malignancies, and pregnancies [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with AESI of infections, malignancies, and pregnancies [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • Number of subjects with other AESI [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Number of subjects with AESIs other than infections and malignancies

  • Percentage of subjects with other AESI [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Number of treatment-emergent AESI per 100 PYs of infections and malignancies [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
  • Number of treatment-emergent other AESI per 100 PYs [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Short Pediatric Crohn's Disease Activity Index (sh-PCDAI) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Patient completed questionnaires

  • Physician's Global Assessment of Disease Activity (PGA) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Completed by the physician

  • IMPACT III [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Completed by caregiver up to the age of 17 years and completed by the patients of age 18 years or above.


Estimated Enrollment: 1300
Study Start Date: August 2014
Estimated Study Completion Date: April 2030
Estimated Primary Completion Date: April 2030 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adalimumab (Humira) Treatment
Pediatric patients who are prescribed and treated with adalimumab
Immunosuppressant Therapy
Pediatric patients who are being prescribed and treated with immunosuppressant therapy

  Eligibility

Ages Eligible for Study:   6 Years to 30 Years
Genders Eligible for Study:   Both
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:

  1. 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 local approved Humira product label.
  2. 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.
  3. 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:

  1. Patients should not be enrolled into the HUMIRA treatment group if they cannot be treated in accordance with the local Humira product label.
  2. Patients should not be enrolled into the registry if they are currently being treated with any investigational agents or are receiving any investigational procedures.
  3. Patients should not be enrolled into the immunosuppressant therapy treatment group if they require ongoing treatment with approved biologic agents including HUMIRA.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130362

Contacts
Contact: Julie Gavigan, BS 847-937-5472 julie.gavigan@abbvie.com
Contact: Andrea Byars, BS 847-937-7904 andrea.byars@abbvie.com

  Show 66 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Andreas Lazar, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02130362     History of Changes
Other Study ID Numbers: P11-292
Study First Received: May 1, 2014
Last Updated: January 26, 2015
Health Authority: Canada: Health Canada
Czech Republic: Ethics Committee
Sweden: Regional Ethical Review Board
Denmark: Danish Dataprotection Agency
Estonia: Research Ethics Committee
Denmark: Danish Health and Medicines Authority

Keywords provided by AbbVie:
Crohn's
Crohn's Disease
Registry
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Adalimumab

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015