RecruitingOBSERVATIONAL

VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study

This study, called VOICE, is looking into how quickly treatments for Crohn's disease, particularly a medication called vedolizumab, start to make a difference. Some people think vedolizumab works slower than other similar drugs for Crohn's. This research will compare how quickly patients feel better when taking vedolizumab versus newer medications like ustekinumab, risankizumab, guselkumab, or mirikizumab. The main way they'll measure this is by asking patients about their pain and other symptoms, like tiredness, anxiety, and sleep, to get a clear picture of how quickly these treatments improve their daily lives. The aim is to get a better understanding for both patients and doctors about what to expect from these important medicines.

At a glance

Status

Recruiting

Sponsor

Alimentiv Inc.

Enrolment target

300

Start

20 Mar 2024

Estimated completion

01 Dec 2026

Crohn's Disease

What is this study about?

If you have Crohn's disease, you'll know that finding a treatment that works well and quickly is really important. This study, called VOICE, is designed to understand how fast certain medications help improve your symptoms. Specifically, it's looking at a drug called vedolizumab, and comparing it to a newer group of medications known as IL-23 antagonists, which include ustekinumab, risankizumab, guselkumab, and mirikizumab.

Some doctors and patients have felt that vedolizumab takes a bit longer to start working compared to other similar treatments. This study wants to check if that idea is truly accurate. It's really important to know this because feeling better quickly can make a big difference to your quality of life. The researchers will be paying close attention to how much pain you feel, your energy levels, how well you sleep, and how you feel generally, using questionnaires you fill out yourself.

The main goal is to get a clearer picture of how quickly these different medications ease symptoms for people with Crohn's. This information will help doctors recommend the best treatment for you, and it will also help you know what to expect when you start a new medicine. By understanding the speed at which these treatments work, both patients and their healthcare teams can make more informed decisions.

Key takeaways

This study helps understand how fast Crohn's disease treatments work.
It focuses on vedolizumab and newer IL-23 antagonist medications.
Your feedback on pain and other symptoms is key to this research.
It's an 'observational study' – you'll receive your usual prescribed medication.
The findings will help doctors and patients make better treatment decisions.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older with a confirmed diagnosis of Crohn's disease. You must have active Crohn's disease and your doctor must be planning to start you on one of the study's medications (vedolizumab, ustekinumab, risankizumab, guselkumab, or mirikizumab) for the very first time. You'll also need to be experiencing at least a certain level of pain related to your Crohn's, which will be checked with a special questionnaire.

There are also some things that would mean you couldn't join. For example, if you're planning to have surgery for your Crohn's disease during the study, or if you've already tried many different advanced Crohn's treatments (other than anti-TNF drugs like infliximab, adalimumab, or certolizumab). If you've tried two or more of these anti-TNF drugs in the last three years and they didn't work for you or caused problems, you also wouldn't be able to join.

Finally, if you have an active infection that needs strong antibiotics into your vein, or if you have a specific gut infection called C. difficile, you wouldn't be able to take part. Your doctor will need to make sure all usual health checks are done before you start treatment.

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 a confirmed diagnosis of Crohn's disease?
Is your doctor planning to start you on vedolizumab, ustekinumab, risankizumab, guselkumab, or mirikizumab for the first time?
Are you currently experiencing pain related to your Crohn's disease?
Are you not planning to have Crohn's-related surgery soon?
Have you not tried many different advanced Crohn's treatments before (apart from anti-TNF drugs, and not too many of them)?

Answer every question to see your result.

What does participation involve?

This is an observational study, which means you'll be taking the medication your doctor has already prescribed for your Crohn's disease as part of your usual care. You won't be given new or experimental drugs specifically for the study. Your participation will mainly involve regularly filling out patient-reported questionnaires about your pain, tiredness, anxiety, sleep, and overall well-being. These questionnaires will help the researchers understand how quickly your symptoms improve. The study will not involve extra hospital visits beyond your normal appointments with your doctor for your Crohn's treatment, nor will it involve different medications than what your doctor recommends.

Potential risks and benefits

Since this is an observational study, you will be receiving standard treatments for Crohn's disease that your doctor has already prescribed. This means you won't be exposed to any experimental drugs or procedures, and the risks directly from the study itself are very low, primarily related to the time taken to complete questionnaires. Potential benefits include contributing important information that could help future patients and doctors understand how quickly different Crohn's treatments work, leading to better-informed choices. You are free to stop participating in the study at any time without affecting your medical care.

Locations (25)

GI Alliance - Sun City
Verified postcode
Sun City, United States· Recruiting
Digestive and Liver Center of Florida
Verified postcode
Kissimmee, United States· Withdrawn
Northwestern University
Verified postcode
Evanston, United States· Recruiting
University of Iowa
Verified postcode
Iowa City, United States· Recruiting
University Medical Center New Orleans
Verified postcode
New Orleans, United States· Recruiting
Brigham and Women's Hospital
Verified postcode
Chestnut Hill, United States· Recruiting
University of North Carolina
Verified postcode
Chapel Hill, United States· Recruiting
Cleveland Clinic Foundation
Verified postcode
Cleveland, United States· Recruiting
OR Clinic - East - GI
Verified postcode
Portland, United States· Recruiting
GI Alliance Research Fort Worth
Verified postcode
Fort Worth, United States· Recruiting
GI Alliance Research Mansfield
Verified postcode
Mansfield, United States· Recruiting
GI Alliance - Bellevue - Washington Gastroenterology
Verified postcode
Bellevue, United States· Recruiting

Common questions

What is an 'observational study'?

It means researchers will watch and record what happens during your usual treatment. You'll take your prescribed medication as normal, and the study will collect information about how you're doing.

Will I have to take different medication than my doctor prescribes?

No, you will take the medication your doctor has already decided is best for you as part of your standard care. The study doesn't change your treatment plan.

How will the study measure if the treatment is working?

You'll fill out questionnaires about how you feel, including your pain, energy levels, and sleep. These questionnaires are an important way for the study to understand your experience.

How long will I be part of the study?

The study focuses on the early response to treatment, so it would involve tracking your progress over a period after you start your medication. The exact duration will be explained by the study team.

What is Crohn's disease?

Crohn's disease is a long-term condition where parts of the digestive system become inflamed. It can cause symptoms like tummy pain, diarrhoea, tiredness, and weight loss.

How to find out more

Susan Archer

susan.archer@alimentiv.com 226-919-6959 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.