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)

NCT02130362 · tracked via the Priya Life Science Italy tracker

Sponsor

AbbVie

Phase

Observational

Started

2014-08-28

Last updated

2025-07-16

Condition(s) studied

Crohn's Disease

Study 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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

17 Years

Healthy volunteers

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.

Primary outcome measure(s)

Number of treatment-emergent AESI per 100 PYs of infections and malignancies — Up to 10 years
Percentage of subjects with SAEs — Up to 10 years
Number of treatment-emergent other AESI per 100 PYs — Up to 5 years
Percentage of subjects with other AESI — 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 — Up to 10 years
Number of subjects with other AESI — Up to 5 years
Number of subjects with AESIs other than infections and malignancies
Number of treatment-emergent SAEs per 100 patient years (PYs) — Up to 10 years
Number of subjects with Serious Adverse Events (SAEs) — Up to 10 years
Percentage of subjects with AESI of infections, malignancies, and pregnancies — Up to 10 years

Trial sites (148)

Facility	City	Region
Univ Alabama, Birmingham CCC /ID# 146060	Birmingham	Alabama
University of South Alabama /ID# 137255	Mobile	Alabama
Phoenix Children's Hospital /ID# 141336	Phoenix	Arizona
Children's Hospital Los Angeles /ID# 141551	Los Angeles	California
Private practice: Dr. Shervin Rabizadeh /ID# 137269	Los Angeles	California
Rady Children's Hospital San Diego /ID# 140883	San Diego	California
Univ California, San Francisco /ID# 141312	San Francisco	California
Children's Hospital Colorado - Aurora /ID# 137261	Aurora	Colorado
Connecticut Children's Medical Center - Hartford /ID# 137265	Hartford	Connecticut
Yale University School of Medicine /ID# 137257	New Haven	Connecticut
Nemours Children's Health System /ID# 148498	Jacksonville	Florida
University of Miami /ID# 140893	Miami	Florida
Winship Cancer Institute of Emory University /ID# 144274	Atlanta	Georgia
Children's Ctr Digestive, US /ID# 144625	Atlanta	Georgia
Children's Hospital New Orleans /ID# 144477	New Orleans	Louisiana
Maine Medical Partners /ID# 147685	Portland	Maine
Tufts Medical Center /ID# 143581	Boston	Massachusetts
Massachusetts General Hospital /ID# 141552	Boston	Massachusetts
Boston Children's Hospital /ID# 164102	Boston	Massachusetts
Duplicate_UMass Chan Medical School /ID# 148325	Worcester	Massachusetts
M Health Fairview University of Minnesota Medical Center - East Bank /ID# 137238	Minneapolis	Minnesota
Mayo Clinic - Rochester /ID# 149245	Rochester	Minnesota
Univ of Mississippi Med Ctr,US /ID# 137239	Jackson	Mississippi
Goryeb Children's Hospital /ID# 144275	Morristown	New Jersey
Women and Childrens Hosp /ID# 143778	Buffalo	New York
CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266	New Hyde Park	New York
Columbia Univ Medical Center /ID# 144440	New York	New York
Columbia Univ Medical Center /ID# 144475	New York	New York
Univ Med Ctr at Stony Brook /ID# 140913	Stony Brook	New York
SUNY Upstate Medical University /ID# 148437	Syracuse	New York
Univ NC Chapel Hill /ID# 137236	Chapel Hill	North Carolina
Duke Cancer Center /ID# 137268	Durham	North Carolina
Children's Hospital Oklahoma /ID# 144047	Oklahoma City	Oklahoma
Geisinger Medical Center /ID# 149910	Danville	Pennsylvania
Penn State Child Hosp.Hersh,PA /ID# 144476	Hershey	Pennsylvania
Duplicate_Medical University of South Carolina /ID# 144473	Charleston	South Carolina
Children's Medical Center /ID# 149256	Dallas	Texas
Cook Children's Med. Center /ID# 144474	Fort Worth	Texas
Texas Children's Hospital /ID# 148211	Houston	Texas
University Of Vermont Medical /ID# 137263	Burlington	Vermont

+ 108 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease Recruiting

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients Active, not recruiting

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02130362 on ClinicalTrials.gov ↗ ← All trials in Italy