A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
This study is for adults with moderate to severe ulcerative colitis, especially those who haven't responded well to previous treatments. We're testing a combination of two medicines, vedolizumab and tofacitinib, to see how effective they are when used together. For the first eight weeks, all participants will receive both medicines. After this initial period, if their condition has improved, they will continue with only vedolizumab for a further 44 weeks. The main goal is to understand how well this combined approach works in helping people with ulcerative colitis. The study will also follow participants for several months after their last dose to check on their health and safety.
Överblick
Vad handlar denna studie om?
If you have ulcerative colitis (UC), you know it can be a challenging condition to manage. This study is looking into a new way to treat adults who have moderate to severe UC, especially if other treatments haven't worked well for them. We're investigating if combining two existing medicines, vedolizumab and tofacitinib, can be a more effective way to help people feel better.
The study aims to understand how well this combination works and if it can help more people achieve 'remission' – a time when symptoms are much reduced or disappear. After an initial period where both medicines are given together, we'll see if continuing with just one of the medicines (vedolizumab) can maintain these improvements. This is about finding the best strategies to help people living with UC lead more comfortable lives.
It's important to know that this is a 'Phase 4' study. This typically means the medicines involved are already approved for use, but researchers want to learn more about how they work together, in different groups of people, or over longer periods. The goal is always to improve understanding of how to best treat conditions like UC.
Viktiga punkter
- Tests a combination of two medicines (vedolizumab and tofacitinib) for ulcerative colitis.
- Aimed at adults with moderate to severe UC who haven't responded to previous treatments.
- Initial 8 weeks of both medicines, then 44 weeks of one if you respond well.
- Study duration up to 76 weeks (about 1.5 years) with follow-up.
- Participation is voluntary; you can withdraw at any time.
Vem kan vara berättigad?
To be considered for this study, you need to be an adult between 18 and 65 years old and have been diagnosed with ulcerative colitis for at least three months. Your UC should be considered moderate to severe at the time of screening.
A key requirement is that you've already tried and not responded well to, stopped responding to, or couldn't tolerate at least one, but no more than two, specific types of medicines called TNF antagonists. If you haven't tried any 'biologic' medicines before, you generally won't be able to join this study, unless specific conditions are met and discussed with the medical team.
Also, if you're currently taking steroid medications, your dose needs to have been stable for at least two weeks before your initial screening appointment. The study also has some rules about colonoscopies and checking for bowel cancer risk, depending on your personal medical history.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Are you an adult aged between 18 and 65?
- Har du en bekräftad diagnos av måttlig till svår ulcerös kolit?
- Have you tried and not responded well to at least one, but no more than two, TNF antagonist medications?
- If you're on steroids for UC, has your dose been stable for at least 2 weeks?
- Are you able to attend regular appointments and follow the study schedule?
Vad innebär deltagande?
If you join this study, it could last for up to 76 weeks, which is about a year and a half. For the first 8 weeks, you will receive both vedolizumab and tofacitinib. These will be given to you as directed by the study team. After these 8 weeks, your progress will be carefully checked. If your condition has improved, you will then continue taking only vedolizumab for another 44 weeks.
Throughout the study, you'll have regular appointments and checks to see how you're responding to the treatment and to monitor your health. These visits will help the doctors understand if the treatment is working and if there are any side effects. Even after you stop taking the study medicine, you'll be followed up for at least 26 weeks (about six months) to ensure your continued well-being. The study will take place in medical centres in the United States and Canada.
Potentiella risker och fördelar
Platser (49)
- Digestive Health SpecialsitsVerifierat postnummerDothan, USA· Rekrytering
- GI Alliance Sun CityVerifierat postnummerSun City, USA· Rekrytering
- Cedars-Sinai medicinska centrumVerifierat postnummerLos Angeles, USA· Rekrytering
- Hoag Sjukhus Newport BeachVerifierat postnummerNewport Beach, USA· Rekrytering
- Endoscopic Research IncVerifierat postnummerOrlando, USA· Rekrytering
- Alliance Clinical Research of Tampa, LLCVerifierat postnummerTampa, USA· Rekrytering
- Gastroenterology Consultants, P.C.Verifierat postnummerRoswell, United States· Rekrytering
- University of Chicago MedicineVerifierat postnummerChicago, USA· Rekrytering
- GI Alliance - Illinois Gastroenterology Group - GlenviewVerifierat postnummerGlenview, USA· Rekrytering
- GI Alliance - Illinois Gastroenterology Group LLC - GurneeVerifierat postnummerGurnee, United States· Rekrytering
- University of Kansas Medical CenterVerifierat postnummerKansas City, USA· Rekrytering
- University of LouisvilleVerifierat postnummerLouisville, USA· Rekrytering
Vanliga frågor
Vad är ulcerös kolit?
Ulcerative colitis is a long-term condition where the lining of the large intestine (colon and rectum) becomes inflamed and develops tiny open sores (ulcers).
What are vedolizumab and tofacitinib?
These are types of medicine used to treat ulcerative colitis. Vedolizumab is given through a drip (IV), and tofacitinib is taken as a tablet.
Why combine these two medicines?
Researchers want to see if using both medicines together works better for people with ulcerative colitis, especially those who haven't responded well to other treatments before.
Hur länge kommer jag att vara med i studien?
If you take part, you could be in the study for up to about a year and a half, with medicine given for up to 52 weeks and follow-up checks after that.
Kan jag lämna studien när som helst?
Yes, you are free to leave the study at any point, and it won't affect your regular medical care.
Hur du får reda på mer
Takeda Kontakt
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
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Diskussion
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