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Clinical Trials in Ireland / NCT02130362
Active, not recruiting

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 Ireland tracker
Sponsor
AbbVie
Phase
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
No
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)

Trial sites (148)

FacilityCityRegionStatus
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.

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 Ireland