Active not recruitingOBSERVATIONAL

A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

This study is a long-term look at a medicine called Humira (adalimumab) for adults living with moderately to severely active ulcerative colitis. Ulcerative colitis is a long-term condition that affects the large bowel, causing inflammation and ulcers. The study aims to understand how safe Humira is and how well it works over a long period when given as doctors usually recommend. Researchers will collect information from patients who are already taking Humira in their daily lives. They are interested in seeing how people respond to the treatment, if their symptoms improve, and if they experience any side effects. The goal is to gather real-world information to help doctors and patients understand more about using Humira for this condition.

At a glance

Status

Active not recruiting

Sponsor

AbbVie

Enrolment target

8,250

Start

29 Apr 2013

Estimated completion

01 Jun 2028

Ulcerative Colitis (UC)

What is this study about?

This study is about a medicine called Humira, which is used to treat a bowel condition known as ulcerative colitis. Ulcerative colitis causes long-lasting inflammation and sores in the large bowel, leading to symptoms like tummy pain and frequently needing to go to the toilet. Humira works by calming down the immune system to reduce this inflammation.

Instead of testing a new medicine, this study is a 'registry study'. This means researchers are observing people who are already being treated with Humira in their usual healthcare. They want to collect information over a long time from these patients to see how Humira works for them in the real world – how effective it is at controlling their symptoms and if there are any side effects. This helps doctors understand the long-term effects of the medicine better.

The main aim is to get a clearer picture of Humira's long-term safety and how well it helps adults with moderate to severe ulcerative colitis when prescribed in the way doctors usually do. This kind of information is very helpful for improving care and advising other patients in the future.

Key takeaways

Study focuses on Humira for moderate to severe ulcerative colitis.
It's about long-term safety and effectiveness in real-world use.
You must be an adult already taking Humira or similar therapy.
No new medication or experimental treatment involved.
Your medical information will be collected from routine appointments.
Helps doctors understand Humira's long-term effects for future patients.

Who may be eligible?

To join this study, you need to be an adult (age 18 or older) who has been diagnosed with moderate to severe ulcerative colitis.

You might be able to join one of two groups. If you're in the group for Humira, you must already be taking Humira and have been on it for at least 8 weeks. Or, you might have been part of an earlier study for ulcerative colitis sponsored by the same company and have been taking Humira continuously since then. There's also another group for patients taking a different type of medicine often used for ulcerative colitis, called an immunosuppressant (IMM therapy), and you must have been taking it for at least 12 weeks.

You can't join this study if you're taking any other new, experimental medicines or other powerful biological medicines besides Humira. Also, if you're taking the IMM therapy but can't continue with it, you wouldn't be able to join that group.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have moderate to severe ulcerative colitis?
Are you currently taking Humira and have been for at least 8 weeks?
Or, are you taking a different immunosuppressant medicine for at least 12 weeks?
Are you *not* taking other experimental or biological medicines (apart from Humira)?
Are you willing for your general medical information about your condition and treatment to be shared for research?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be in a registry, which means researchers will collect information about your health and your Humira treatment over a long period. This usually involves your doctor sharing details from your regular medical check-ups and appointments with the study. You won't be given new or experimental treatments; you'll continue with your Humira as prescribed by your own doctor as part of your usual care.

Participation generally involves allowing your medical information related to your ulcerative colitis and Humira treatment to be shared with the study team. This includes details from your routine doctor visits, tests, and how you are feeling. You would not typically have extra doctor visits or take different medication because of the study itself. The total duration of your participation would depend on how long the registry is planned to run, but these types of studies often track patients for several years.

Potential risks and benefits

Taking part in this study may not directly benefit you, as you will continue with your usual treatment for ulcerative colitis. However, your participation will help doctors and researchers learn more about the long-term safety and effectiveness of Humira, which could help many other patients with ulcerative colitis in the future. As you are already taking Humira, you are already aware of its potential side effects, which could range from mild injection site reactions to more serious infections. The main risk in this study is related to the collection and sharing of your medical data, though all reasonable steps will be taken to keep your information private. You are free to withdraw from the study at any time without affecting your medical care.

Locations (512)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Birmingham Gastroenterology Associates P.C /ID# 102063
Verified postcode
Birmingham, United States
University of Alabama at Birmingham - Main /ID# 131646
Verified postcode
Birmingham, United States
Longwood Research /ID# 118662
Verified postcode
Huntsville, United States
East View Medical Research, LLC /ID# 116259
Verified postcode
Mobile, United States
Mobile Medical & Diagnostic Center, AL /ID# 102064
Verified postcode
Mobile, United States
HOPE Research Institute /ID# 127947
Verified postcode
Phoenix, United States
Duplicate_University of Arizona Cancer Center - North Campus /ID# 140387
Verified postcode
Tucson, United States
University Of Arizona /ID# 117836
Verified postcode
Tucson, United States
Arkansas Gastroenterology /ID# 113898
Verified postcode
North Little Rock, United States
Southern California Res. Ctr. /ID# 116898
Verified postcode
Coronado, United States
Moores Cancer Center at UC San Diego /ID# 133722
Verified postcode
La Jolla, United States
McGuire, Jr. La Mirada, CA /ID# 116257
Verified postcode
La Mirada, United States

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where your large bowel (colon and rectum) becomes inflamed and develops small sores, causing symptoms like tummy pain and diarrhoea.

What is Humira?

Humira (adalimumab) is a medicine used to treat several inflammatory conditions, including ulcerative colitis, by helping to reduce inflammation in your body.

Is this a typical drug trial?

No, this is a 'registry study'. It collects information on how Humira works for people who are already taking it as part of their routine care, rather than testing a new medicine.

Will I get different treatment if I join?

No, you will continue with your current Humira treatment as prescribed by your own doctor. The study just collects information about your ongoing care.

Will my personal data be kept private?

Yes, researchers are required to protect your personal information and ensure any data shared for the study is handled confidentially and securely.