Ongoing, recruitingTherapeutic use (Phase IV)Interventional

(A)nalysis of immunological (VA)riables in ex vivo (T)ofacitinib-treated human biopsies from (A)ctive ulcerative colitis patients to predict clinical (R)esponse (the AVATAR study).

This research study, called AVATAR, is looking into a medicine called Xeljanz (also known as tofacitinib) for adults with ulcerative colitis. We want to understand how this medicine works on the body's immune system. Researchers will study small samples (biopsies) taken from patients who have active ulcerative colitis. By looking closely at these samples after they've been treated with Xeljanz in the lab, we hope to find early signs that can predict whether a patient will respond well to this treatment when they take it. This could help doctors choose the best treatment for individual patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Universita' Degli Studi Di Roma Tor Vergata

Enrolment target

Start

19 Nov 2024

Ulcerative colitis

What is this study about?

This study is called AVATAR, and it's looking into a condition called ulcerative colitis. Ulcerative colitis is a long-term condition where the lining of the large intestine (colon) becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, diarrhoea, and blood in your poo. The study focuses on a medicine called Xeljanz (also known as tofacitinib), which is already approved and used for treating ulcerative colitis. This study is a 'Phase IV' one, which means it's looking more deeply into a treatment that's already in use. It's not testing a brand new medicine, but rather trying to understand the current treatment better.

Now, how does this study work? Researchers will take small tissue samples, called biopsies, from patients who have active ulcerative colitis. These biopsies will then be treated with Xeljanz in a laboratory, outside of the patient's body. The scientists will be looking at what happens to the immune cells within these samples. They want to see if Xeljanz causes specific changes in these cells early on.

The main goal is to figure out if these early changes, seen in the lab, can help predict which patients will respond well to Xeljanz if they take it. By understanding this better, doctors might be able to tell with more accuracy whether Xeljanz is likely to help a particular patient. This could lead to more personalised treatment choices, helping patients get the right medicine for them sooner.

Key takeaways

The study aims to understand how Xeljanz works at a cell level.
It uses tissue samples from people with active ulcerative colitis.
The goal is to predict who will respond well to Xeljanz treatment.
You won't take Xeljanz as part of this study.
Your standard medical procedure biopsies are used.
It could help doctors choose better treatments in the future.

Who may be eligible?

This study is specifically looking for adults who have ulcerative colitis. To take part, you need to be at least 18 years old, but there's no upper age limit. Both men and women can join the study.

The most important thing is that you have active ulcerative colitis. This means your condition is currently causing symptoms and inflammation. The researchers are looking for people whose bodies are actively fighting this condition, as they want to see how the treatment affects this activity.

While this summary gives a general idea, the full list of things that make someone eligible or not eligible is usually longer and more detailed. Your doctor will be able to check all the specific requirements if you're interested.

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?
Is your ulcerative colitis currently active (causing symptoms or inflammation)?
Are you comfortable with researchers using your biopsy samples (taken during routine care) for this study?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve giving permission for researchers to use small tissue samples (biopsies) that are already being taken for your usual care, for example, during a colonoscopy. You would not typically need extra visits or procedures just for this study. The study looks at how your tissue samples react to the medicine in a lab, not at you taking the medication directly as part of the study itself. There is no medication to take, no specific follow-up appointments related to the study, and no long-term commitment. The total duration of your participation would be limited to the time it takes to provide your consent and for the researchers to collect and analyse your biopsy samples.

Potential risks and benefits

A potential benefit of taking part is that your contribution may help doctors in the future better understand how Xeljanz works for ulcerative colitis, potentially leading to more targeted and effective treatments for others. As you are not taking any study medication and no extra procedures are performed just for the study, the direct risks to you are minimal, mainly related to the standard biopsy procedure you would undergo anyway. You are always free to change your mind and withdraw your consent to participate at any time, without it affecting your medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large intestine (colon) becomes inflamed and can develop small sores, causing tummy pain, diarrhoea, and sometimes blood in your poo.

What is Xeljanz (tofacitinib)?

Xeljanz is a medicine used to treat ulcerative colitis. It works by affecting the immune system to reduce inflammation in the bowel.

Will I be given Xeljanz in this study?

No, you will not be given Xeljanz to take as part of this study. Your tissue samples will be treated with the medicine in a lab, outside of your body.

What will I have to do if I join?

If you join, researchers will use small tissue samples (biopsies) that you would already have taken during your regular medical care. You won’t need extra visits or procedures just for the study.

Will this study help me directly?

This study won't directly change your current treatment or immediately improve your health. However, your contribution will help future research and potentially lead to better care for people with ulcerative colitis in the long run.