Active not recruitingOBSERVATIONAL

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 study is for children aged 6 to 17 who have moderate to severe Crohn's disease. Doctors want to understand the long-term effects of Humira in young patients who are already taking it as part of their regular care. They'll also follow children taking other common Crohn's medicines like azathioprine, 6-mercaptopurine, or methotrexate, to compare experiences. This isn't a study where you get a new or experimental medicine; instead, it's about watching how existing treatments work in real life over time. The main goal is to gather information about the safety and how well these treatments control Crohn's disease in children over many years.

At a glance

Status

Active not recruiting

Sponsor

AbbVie

Enrolment target

1,446

Start

28 Aug 2014

Estimated completion

01 Nov 2030

Crohn's Disease

What is this study about?

This study is all about understanding how a medicine called Humira works in children and teenagers (aged 6 to 17) who have moderate to severe Crohn's disease. When we say 'moderate to severe,' it means their Crohn's is active and might be causing quite a few symptoms. The important thing to know is that this study isn't testing a new medicine; instead, it's carefully watching patients who are already prescribed Humira by their doctor as part of their usual care.

The study also includes another group of young people with Crohn's disease who are taking other common treatments, such as azathioprine, 6-mercaptopurine, or methotrexate, which are medicines often used to calm down the immune system. By looking at these two groups, doctors can gather information over a long time about how safe these treatments are and how well they help manage Crohn's disease in the real world.

Think of it like doctors gathering ongoing information. They are simply observing and collecting details about how young patients are doing on these established medicines over many years. This helps them learn more about the long-term effects of treatments for Crohn's disease in children and understand what works best for patients in the long run.

Key takeaways

Study for children aged 6-17 with moderate to severe Crohn's disease.
Compares Humira to other common Crohn's medicines.
Not testing new drugs; observing long-term effects of existing treatments.
Information gathered from routine doctor visits.
Aims to understand long-term safety and how well treatments work.
You can stop participating at any time.

Who may be eligible?

To join the study, you need to be a child or teenager between 6 and 17 years old with moderate to severe Crohn's disease. You'll either be taking Humira as prescribed by your doctor, or you'll be taking another common Crohn's medicine like azathioprine, 6-mercaptopurine, or methotrexate.

It's also really important that a parent or guardian, or you if you're 18 and over, understands the study and agrees to take part. This means signing a form after everything has been explained and you've had a chance to ask questions.

You cannot join this study if you are currently taking part in another study that involves experimental medicines or procedures. Also, if you're in the group taking azathioprine, 6-mercaptopurine, or methotrexate, you can't be taking other biologic medicines (like Humira) at the same time.

Quick self-check

Are you between 6 and 17 years old?
Do you have moderate to severe Crohn's disease?
Are you currently prescribed Humira, OR azathioprine, 6-mercaptopurine, or methotrexate for your Crohn's?
Are you NOT currently taking part in another study with experimental medicines?
If taking azathioprine, 6-mercaptopurine, or methotrexate, are you NOT also taking other biologic medicines like Humira?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you won't be given any new or experimental medicines; you'll simply continue with the Crohn's treatment your doctor has already prescribed, whether that's Humira or another common medicine. The study involves collecting information about your regular medical visits and how your Crohn's disease is doing over a long period. This means your doctors will share details from your routine check-ups and test results with the study team. You won't have extra visits just for the study, but rather the study team will gather information from your existing appointments. The exact duration of your participation isn't specified, but it's designed to gather long-term information, so it may involve several years of data collection.

Potential risks and benefits

Participating in this study might not directly benefit you, as you'll be receiving the same care you would normally. However, the information gathered could help doctors better understand the long-term safety and effectiveness of Crohn's disease treatments for children in the future. As this is an observational study, where you continue your usual treatment, the risks are generally low and associated with your usual medical care, not the study itself. You are free to withdraw from the study at any time without affecting your medical care.

Locations (148)

Univ Alabama, Birmingham CCC /ID# 146060
Birmingham, United States
University of South Alabama /ID# 137255
Mobile, United States
Phoenix Children's Hospital /ID# 141336
Phoenix, United States
Children's Hospital Los Angeles /ID# 141551
Los Angeles, United States
Private practice: Dr. Shervin Rabizadeh /ID# 137269
Los Angeles, United States
Rady Children's Hospital San Diego /ID# 140883
San Diego, United States
Univ California, San Francisco /ID# 141312
San Francisco, United States
Children's Hospital Colorado - Aurora /ID# 137261
Aurora, United States
Connecticut Children's Medical Center - Hartford /ID# 137265
Hartford, United States
Yale University School of Medicine /ID# 137257
New Haven, United States
Nemours Children's Health System /ID# 148498
Jacksonville, United States
University of Miami /ID# 140893
Miami, United States

+136 more sites — see the official record for the full list.

Common questions

What is Crohn's disease?

Crohn's disease is a long-term condition that causes inflammation in your digestive system. This can lead to symptoms like tummy pain, diarrhoea, and weight loss.

What is Humira?

Humira is a medicine often used to treat conditions like Crohn's disease. It works by reducing inflammation in the body.

Will I get new medicine in this study?

No, you will not be given new medicine. This study is about watching how well your existing Crohn's disease medicine works over time.

Do I have extra appointments for this study?

No, you won't have extra appointments just for the study. Information will be collected from your regular doctor visits.

Can I leave the study at any time?

Yes, you or your child can choose to stop participating in the study at any time, and it will not affect your medical care.