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)

Running, not enrolling

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT02130362

Run by

AbbVie

People needed

1446

Starts

2014-08-28

Expected to finish

2030-11-01

Last updated by the study team

2025-07-16

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of South Alabama /ID# 137255 — Mobile, Alabama, United States
• Phoenix Children's Hospital /ID# 141336 — Phoenix, Arizona, United States
• Children's Hospital Los Angeles /ID# 141551 — Los Angeles, California, United States
• Private practice: Dr. Shervin Rabizadeh /ID# 137269 — Los Angeles, California, United States
• Rady Children's Hospital San Diego /ID# 140883 — San Diego, California, United States
• Univ California, San Francisco /ID# 141312 — San Francisco, California, United States
• Children's Hospital Colorado - Aurora /ID# 137261 — Aurora, Colorado, United States
• Connecticut Children's Medical Center - Hartford /ID# 137265 — Hartford, Connecticut, United States
• Yale University School of Medicine /ID# 137257 — New Haven, Connecticut, United States
• Nemours Children's Health System /ID# 148498 — Jacksonville, Florida, United States
• University of Miami /ID# 140893 — Miami, Florida, United States
• Winship Cancer Institute of Emory University /ID# 144274 — Atlanta, Georgia, United States
• Children's Ctr Digestive, US /ID# 144625 — Atlanta, Georgia, United States
• Children's Hospital New Orleans /ID# 144477 — New Orleans, Louisiana, United States
• Maine Medical Partners /ID# 147685 — Portland, Maine, United States
• Tufts Medical Center /ID# 143581 — Boston, Massachusetts, United States
• Massachusetts General Hospital /ID# 141552 — Boston, Massachusetts, United States
• Boston Children's Hospital /ID# 164102 — Boston, Massachusetts, United States
• Duplicate_UMass Chan Medical School /ID# 148325 — Worcester, Massachusetts, United States
• M Health Fairview University of Minnesota Medical Center - East Bank /ID# 137238 — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester /ID# 149245 — Rochester, Minnesota, United States
• Univ of Mississippi Med Ctr,US /ID# 137239 — Jackson, Mississippi, United States
• Goryeb Children's Hospital /ID# 144275 — Morristown, New Jersey, United States
• Women and Childrens Hosp /ID# 143778 — Buffalo, New York, United States
• Univ Alabama, Birmingham CCC /ID# 146060 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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