Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290

This study is for children and teenagers who have ulcerative colitis and have already taken part in a previous study using a medicine called Adalimumab, also known as Humira. Ulcerative colitis is a long-term condition that causes inflammation in the large intestine. The main purpose of this new study is to closely watch the long-term safety and how well participants tolerate repeated doses of Humira. It will also look at how effective the treatment continues to be over time. By taking part, you would help doctors understand more about using Humira safely and effectively in young people with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AbbVie Deutschland GmbH & Co. KG

Enrolment target

Start

30 Jan 2024

Ulcerative Colitis

What is this study about?

This study is designed to learn more about a medicine called Adalimumab, which you might know as Humira. It's a treatment used for a condition called ulcerative colitis, which causes inflammation and sores in the lining of your large intestine. This particular study is for young people who have already been using Humira in a previous study.

The main goal is to check the long-term safety of Humira when given repeatedly over time. It's important for doctors to understand how well patients continue to tolerate the medicine and if there are any new side effects that might appear further down the line. Researchers will be observing participants closely to make sure the treatment continues to be suitable and helpful.

We also want to see how well Humira continues to work in managing ulcerative colitis symptoms over a longer period. This information is really important because it helps doctors make the best treatment decisions for young people with this condition, aiming to improve their health and quality of life.

Key takeaways

This study is for adults with ulcerative colitis who've already used Humira.
It aims to check Humira's long-term safety and how well it continues to work.
Your health will be closely watched by medical professionals.
Participation helps doctors understand more about ulcerative colitis treatments.
You can stop participating at any time if you wish.

Who may be eligible?

This study is looking for adults aged 18 years and older. There are no upper age limits, so people of all adult ages can take part.

Both men and women are welcome to participate in this study. The study treats everyone equally and does not have any restrictions based on gender.

To be eligible, you must have ulcerative colitis and have previously completed a specific study called M11-290. This means you would have already received Humira as part of that earlier research.

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 ulcerative colitis?
Did you take part in the previous study M11-290?
Are you interested in continuing to receive Humira treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive your Humira medication. The study team will closely monitor your health and how you are responding to the treatment. This will involve regular visits to the clinic where you might have physical examinations, blood tests, and answer questions about your symptoms and how you are feeling. Doctors will use special tools, like the PMS (Partial Mayo Score) or Mayo score, and the PUCAI (Pediatric Ulcerative Colitis Activity Index), to track how well the treatment is working. The specific number of visits and the full duration of your participation will be explained in detail by the study team, but it will be for a longer period to assess long-term effects.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as continuing to receive treatment for your ulcerative colitis and having your health closely monitored by specialists. Your participation also helps doctors learn more about the long-term safety and effectiveness of Humira, which could help many other young people with ulcerative colitis in the future. However, like all medicines, Humira can have side effects, and some people might experience discomfort or other issues from blood tests or examinations. You have the right to withdraw from the study at any time, for any reason, without needing to explain why, and this will not affect your usual medical care.

Locations (2)

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

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Unverified
Slovakia
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Unverified
Poland

Common questions

What is ulcerative colitis?

It's a long-term condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops sores.

What is Humira?

Humira (Adalimumab) is a medicine that helps reduce inflammation in conditions like ulcerative colitis by blocking a protein called TNF.

Why is this study only for people who were in another study?

This study wants to follow up on people who have already used Humira to see its long-term safety and effects after receiving it for an extended period.

Will I keep getting the same dose of Humira?

The study involves different doses (20mg, 40mg, 80mg, or 40mg/0.8ml injection), and the dose you receive will be decided by the study doctors based on your condition.

What does 'Phase III' mean?

Phase III means the treatment has already been tested in earlier stages, and now we're confirming how well it works and its safety in a larger group of people.