A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease
This research study is looking at a new drug, guselkumab, for people living with Crohn's disease who have fistulas near their back passage. These fistulas can be very uncomfortable and challenging to treat. The main goal is to find out if guselkumab is effective at healing these fistulas and improving symptoms, and to check for any side effects. Participants will either receive guselkumab or a placebo (a dummy treatment with no active drug) to fairly compare their effects. This is a late-stage study, meaning the drug has already been tested in smaller groups and shows promise. Your participation could help us understand if this new treatment can offer a better quality of life for those affected.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is designed to carefully look at a new treatment called guselkumab for people who have Crohn's disease, specifically when it affects the area around the back passage and causes fistulas. Fistulas are abnormal tunnels or connections that can form between organs or from an organ to the skin, and in Crohn's disease, they often appear around the anus. These can be very painful, leak, and significantly impact daily life.
The main purpose of this research is to see how well guselkumab works to treat these fistulas and if it helps them to heal. We will also be closely watching for any side effects to make sure the medication is safe. Some participants will receive guselkumab, while others will receive a placebo, which looks like the study drug but doesn't contain any active medication. This is a common and important way to fairly assess if the new drug is truly effective.
Finding new and better treatments for perianal fistulas in Crohn’s disease is really important because current options don't work for everyone, and it can be a very difficult condition to manage. By taking part in this study, you could help doctors learn more about this condition and potentially improve future care for many people living with Crohn's.
النقاط الرئيسية
- Tests a new medication (guselkumab) for Crohn's-related fistulas around the back passage.
- Compares guselkumab to a placebo (dummy treatment) to see if it works and is safe.
- Designed for people whose current Crohn's treatments for fistulas haven't been effective.
- Involves regular clinic visits, medical checks, and possibly scans.
- Aims to find better treatment options for this challenging aspect of Crohn's disease.
- المشاركة طوعية، ويمكنك الانسحاب في أي وقت.
من قد يكون مؤهلاً؟
To be considered for this study, you need to have a confirmed diagnosis of Crohn's disease for at least three months. You must also have at least one active fistula around your back passage that is draining, which will be confirmed by a special scan called an MRI.
Importantly, you would have previously tried up to two different types of strong medications for your Crohn's (like infliximab, adalimumab, vedolizumab, or similar drugs including JAK inhibitors) but found they either didn't work initially, stopped working over time, or you couldn't tolerate them due to side effects.
There are also some reasons why you might not be able to join. For example, if your Crohn's disease is very severe in other parts of your gut, if you have certain other medical conditions like rectovaginal fistulas, a stoma that is working, severe blockages, or uncontrolled infections. You also wouldn't be able to join if you have a history of certain other illnesses like systemic lupus erythematosus or multiple sclerosis, or if you have complications of Crohn's that might need surgery soon.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- Do you have a diagnosis of Crohn's disease for at least 3 months?
- Do you have at least one active, draining fistula near your back passage?
- Have you tried and not responded well to at least one strong Crohn's medication?
- Are you between 18 years old and any age (no upper age limit)?
- Do you not have very severe Crohn's in other parts of your gut, or other certain ongoing serious health issues?
ماذا يتضمن المشاركة؟
If you join this study, you would receive either the study drug, guselkumab, or a placebo (a dummy drug). This will be decided by chance. You would have regular visits to the clinic so the study team can monitor your health, check your Crohn's symptoms, and evaluate how the fistulas are responding. This will involve physical examinations, blood tests, and potentially repeat scans like MRIs. You'll also be asked to report any changes in your health or any side effects you experience. The total length of your participation in the study, including all treatments and follow-up, will be explained in detail by the study team, but typically, studies like this involve regular visits over a period of many months.
المخاطر والفوائد المحتملة
Locations (154)
- جامعة ألاباما في برمنغهامالرمز البريدي المؤكدبرمنغهام، الولايات المتحدة
- جامعة ييلالرمز البريدي المؤكدنيو هيفن، الولايات المتحدة
- جامعة مياميالرمز البريدي المؤكدميامي، الولايات المتحدة
- Gastroenterology Group Of Naplesالرمز البريدي المؤكدنابولي، الولايات المتحدة
- AdventHealth Medical Group Blood & Marrow Transplant at Orlandoالرمز البريدي المؤكدأورلاندو، الولايات المتحدة
- مركز جامعة كانساس الطبيالرمز البريدي المؤكدكانساس سيتي، الولايات المتحدة
- University of Kentucky Chandler Medical Centerالرمز البريدي المؤكدLexington, United States
- جامعة لويفيلالرمز البريدي المؤكدلويفيل، الولايات المتحدة
- كلية الطب بجامعة واشنطنالرمز البريدي المؤكدسانت لويس، الولايات المتحدة
- Mount Sinai School of Medicineالرمز البريدي المؤكدنيويورك، الولايات المتحدة
- Digestive Disease Specialists Incالرمز البريدي المؤكدمدينة أوكلاهوما، الولايات المتحدة
- Gastro Oneالرمز البريدي المؤكدGermantown, United States
أسئلة شائعة
ما هو الجوسلكوماب؟
Guselkumab is a potential new medication being tested to treat fistulas in people with Crohn's disease. It works by targeting specific parts of your immune system.
ما هو الدواء الوهمي؟
A placebo is a dummy treatment that looks exactly like the study medication but contains no active drug. It helps researchers fairly compare the new drug's effects.
هل سأعرف إذا كنت أحصل على الدواء الفعال أم الدواء الوهمي؟
No, during the main part of the study, neither you nor your study doctor will know whether you are receiving guselkumab or the placebo. This is to ensure fair and unbiased results.
كم ستستغرق مدة الدراسة؟
The exact duration of your involvement will be explained by the study team, but studies like this usually involve follow-up over many months to properly assess the treatment's effects.
هل يمكنني مغادرة الدراسة في أي وقت؟
Yes, you are free to leave the study at any point, for any reason, without it affecting your medical care.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
نقاش
مناقشة المجتمع
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