FirST lines of biologics in pAtients with ulceRaTivE colitis: a Randomised controlled trial
This research study, called FirST, is investigating new treatments for ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the large intestine. The study is comparing several existing medications (STEQEYMA, Remsima, Jyseleca, and Entyvio) to see which ones are most effective in helping patients achieve and maintain 'remission.' Remission means that your symptoms, like rectal bleeding and frequent trips to the toilet, improve significantly or go away completely, and certain markers in your body show that the inflammation is calming down. We are looking for treatments that can lead to no rectal bleeding, settled bowel habits, and reduced signs of inflammation in your gut, without needing steroids. The study will follow participants for a long time to understand how well these medicines work in the real world.
Em resumo
Sobre o que é este estudo?
This study is a Phase III clinical trial, which means the treatments being tested have already shown promise in earlier research and are now being carefully compared to see how well they work and if they are safe for a wider group of people. The main goal is to find out which of these medicines can help people with ulcerative colitis go into remission. Remission means that your gut inflammation is under control, your symptoms like bleeding and urgent bowel movements are gone, and you don't need to take steroids anymore.
Researchers will be looking at several things to decide if someone is in remission. This includes whether they have any rectal bleeding, if their bowel habits have become more normal, and if a specific test called faecal calprotectin (which measures inflammation in your gut from a stool sample) shows low levels of inflammation. They will check these things every month for nearly a year to see if the treatments are working consistently. By doing this, the study aims to identify the most effective treatments to help people live better with ulcerative colitis.
Beyond just getting into remission, the study will also look at how long people stay well, how their gut looks during check-ups (using flexible scopes, for example), and how happy they are with their treatment. This comprehensive approach helps doctors understand the full picture of how these medicines impact people's lives.
Pontos principais
- Compares different ulcerative colitis medicines (STEQEYMA, Remsima, Jyseleca, Entyvio).
- Aims to find out which treatments help people achieve and stay in 'remission'.
- Remission means no bleeding, normal bowel habits, and low inflammation without steroids.
- Participation involves regular clinic visits, medical checks, and providing samples.
- The study will last for up to two years to see long-term effects.
- Helps improve future treatments for ulcerative colitis patients.
Quem pode ser elegível?
To be able to take part in this study, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate if they meet the other criteria. The study welcomes both men and women.
The most important factor is that you have been diagnosed with ulcerative colitis. This study is specifically designed for people living with this condition.
Before joining, doctors will carefully check your medical history and current health to make sure the study is a safe and suitable option for you. They will explain everything in detail.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Você tem 18 anos ou mais?
- Have you been diagnosed with ulcerative colitis?
- Are you able to attend regular appointments for up to two years?
- Are you willing to potentially receive one of the study medications (infusion or tablet)?
- Are you willing to provide samples (like stool or blood) and undergo medical checks?
O que envolve a participação?
If you decide to take part in this study, you will receive one of the study medications. These medicines are given in different ways: some are infusions (given through a drip), and one is a tablet you take by mouth. The study involves regular visits to the clinic, where you will have check-ups, answer questions about your symptoms, and provide samples (like stool or blood samples). You may also have some endoscopy procedures, where a thin camera is used to look at the inside of your bowel, at certain points in the study.
Your progress will be monitored closely between week 4 and week 52 of the study, and some follow-up will continue for up to 24 months (about two years). These regular appointments allow the doctors to see how well the medicine is working and to keep an eye on your health and any side effects. The total duration of your participation, including follow-up, will be explained fully by the study team.
Riscos e benefícios potenciais
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Perguntas frequentes
What is 'remission' in this study?
Remission means your ulcerative colitis symptoms, like bleeding and frequent bowel movements, are gone or much better, and tests show inflammation is reduced, ideally without needing steroids.
What is faecal calprotectin?
It's a protein measured in a stool sample that helps doctors see how much inflammation there is in your gut. Lower levels are better.
How often will I be checked?
You'll have regular checks, at least monthly for the first year, and then follow-up for up to two years, to see how the treatment is working.
Are the study drugs new?
These are existing medications that have already been developed. This study aims to find out which of these established treatments works best.
Posso parar de participar se eu quiser?
Sim, você pode deixar o estudo a qualquer momento sem dar uma razão, e isso não afetará seu atendimento médico futuro.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Discussão
Discussão da comunidade
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