A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
This study is investigating a new treatment approach for adults living with moderate to severe Crohn's Disease. Researchers want to find out if using two medicines together, vedolizumab and upadacitinib, is more effective at reducing inflammation and ulcers in the bowel than using vedolizumab by itself. They will also carefully monitor the safety of this combination treatment. For the first 12 weeks, all participants will receive vedolizumab along with either upadacitinib or an inactive dummy treatment (placebo). Those who respond well will then continue on vedolizumab alone for nearly a year. The study involves regular clinic visits and aims to advance our understanding of how to best treat Crohn's Disease.
Överblick
Vad handlar denna studie om?
This research study is for adults who have Crohn's Disease that is moderately to severely active. The main goal is to explore whether combining two medications, called vedolizumab and upadacitinib, works better than vedolizumab alone to help reduce inflammation and ulcers in the bowel. Researchers will also be carefully watching for any side effects and how safe the treatments are.
For the first 12 weeks, everyone in the study will receive vedolizumab. Half of the participants will also receive upadacitinib, and the other half will receive a placebo, which looks like upadacitinib but has no active medicine. This helps researchers compare the combination treatment with vedolizumab by itself. After these 12 weeks, if a participant's Crohn's disease shows a good response, they will then continue with vedolizumab alone for about 40 more weeks.
Understanding how different treatments work, alone or in combination, is crucial for improving care for people with Crohn's Disease. This study could help doctors make more informed decisions about the best ways to manage this condition in the future.
Viktiga punkter
- Tests vedolizumab with and without a second drug, upadacitinib.
- For adults with moderate to severe Crohn's Disease.
- Aims to reduce bowel inflammation and ulcers.
- Involves 15 clinic visits over about 70 weeks.
- Participants may receive a placebo in the initial phase.
- Careful monitoring of safety and effectiveness.
Vem kan vara berättigad?
To join this study, you must be an adult between 18 and 65 years old with Crohn's Disease that has been diagnosed for at least three months. Your Crohn's disease must be considered moderately to severely active, and you should have signs of inflammation in your bowel, confirmed by special scans or tests.
It's important that previous treatments for your Crohn's disease, such as steroids, immune-suppressing drugs, or other biological medicines, haven't worked well enough for you, or you couldn't tolerate them.
There are also reasons why you might not be able to join. For example, if you have a different bowel condition like ulcerative colitis, or if you currently have a serious infection. Also, if you have certain complications from Crohn's Disease that might need surgery soon, such as blocked bowels or abscesses, or if you have severe kidney or liver problems, you wouldn't be able to take part.
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.
- Är du mellan 18 och 65 år gammal?
- Do you have a confirmed diagnosis of moderately to severely active Crohn's Disease?
- Have other Crohn's treatments not worked well for you or caused problems?
- Do you currently have a serious infection or severe kidney/liver problems?
- Do you have any severe complications from Crohn's that might need surgery soon?
Vad innebär deltagande?
If you join this study, you'll be involved for about 70 weeks, which is roughly a year and four months. For the first 12 weeks, you'll receive a combination of medicines (vedolizumab plus either upadacitinib or a placebo). If your condition improves significantly, you'll then switch to receiving vedolizumab by itself for the next 40 weeks. After finishing the treatment, there will be a follow-up period of about 18 weeks to check on your health and safety. You will need to visit the study clinic about 15 times over the course of the study for check-ups and assessments.
Potentiella risker och fördelar
Locations (138)
- UCSD Medical CenterVerifierat postnummerLa Jolla, USA· Rekryterar inte ännu
- Keck Medicine Of USC - USC Healthcare Center 1Verifierat postnummerLos Angeles, USA· Rekryterar inte ännu
- Peak Gastroenterology AssociatesVerifierat postnummerColorado Springs, USA· Rekrytering
- GI PROS, Inc.Verifierat postnummerNeapel, USA· Aktiv men inte rekryterande
- Orlando Health Ambulatory Care CenterVerifierat postnummerOrlando, USA· Aktiv men inte rekryterande
- USF Health Morsani Center for Advanced HealthcareVerifierat postnummerTampa, USA· Aktiv men inte rekryterande
- Indiana University (IU) Health University HospitalVerifierat postnummerIndianapolis, USA· Aktiv men inte rekryterande
- University of KentuckyVerifierat postnummerLexington, USA· Aktiv men inte rekryterande
- Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical CenterVerifierat postnummerNew York, USA· Aktiv men inte rekryterande
- Columbia University Medical Center, New York-Presbyterian HospitalVerifierat postnummerNew York, USA· Rekryterar inte ännu
- Lenox Hill Hospital Northwell HealthVerifierat postnummerNew York, USA· Aktiv men inte rekryterande
- Gastroenterology AssociatesVerifierat postnummerGreenville, USA· Aktiv men inte rekryterande
Vanliga frågor
What is Crohn's Disease?
Crohn's Disease is a long-term condition that causes inflammation in the digestive system, leading to symptoms like tummy pain, diarrhoea, and weight loss.
What are vedolizumab and upadacitinib?
These are medicines used to treat inflammatory conditions like Crohn's Disease by targeting specific parts of the immune system to reduce inflammation.
Vad betyder 'placebo'?
A placebo is an inactive substance or treatment that looks the same as the real medicine but contains no active drug. It helps researchers compare the effects of the active medicine.
Hur länge kommer studien att pågå?
The entire study will last for approximately 70 weeks, which is about one year and four months.
Will I know which treatment I am receiving?
During the first 12 weeks, you won't know if you're receiving upadacitinib or the placebo along with vedolizumab. This is standard in studies to ensure fair comparison of treatments.
Hur du får reda på mer
Takeda Kontakt
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