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NCT Number: NCT02130362

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)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinical Center Tuzla /ID# 130638, Tuzla, Tuzlanski, Bosnia and Herzegovina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Acronym: CAPE

Important dates

Study start
2014
Primary completion
2030
Study completion
2030
First posted
May 5, 2014
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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