A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
This study is testing a medicine called guselkumab in children and teenagers (aged 2 to 17) who have moderately to severely active Crohn's disease. Crohn's disease can cause inflammation in the gut, leading to symptoms like tummy pain and frequent toilet trips. The main aim is to see how effective guselkumab is over 52 weeks (about one year) for patients who showed improvement in their symptoms after the first 12 weeks of treatment. Researchers will use special tests, like internal cameras (endoscopy), to check the healing of the gut lining. This is a Phase 3 study, meaning it's a larger trial happening after initial safety and effectiveness tests, bringing it closer to potentially being available to more patients.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
Crohn's disease is a condition that causes long-term inflammation in your digestive system. This can lead to symptoms like tummy pain, diarrhoea, weight loss, and feeling very tired. For some children and teenagers, these symptoms can be quite severe and impact their daily lives.
This particular study is looking into a medicine called guselkumab. It’s being tested in young people aged 2 to 17 who have Crohn’s disease that isn't well controlled by other treatments, or who haven't been able to tolerate them. The study wants to find out if guselkumab can effectively reduce the inflammation and symptoms caused by Crohn’s after one year of treatment, especially for those who show early improvement.
The researchers will be monitoring participants closely to see how well the medicine helps heal the gut lining. This information is important because it could help doctors understand if guselkumab is a safe and effective new option for treating Crohn's disease in young people in the future.
النقاط الرئيسية
- This study is for children and teenagers (2-17 years old) with Crohn's disease.
- It tests a medicine called guselkumab over one year.
- Aims to see if it helps reduce symptoms and heal the gut lining.
- It's for those whose current treatments haven't worked well.
- Participants will have regular medical check-ups and tests.
من قد يكون مؤهلاً؟
To join this study, you (or your child) must have been diagnosed with Crohn's disease that currently causes moderate to severe symptoms. Doctors will confirm this using a special scoring system and internal camera tests (endoscopy) to check for active inflammation in the gut.
You would also need to have tried other common treatments for Crohn's disease in the past, such as certain immune-suppressing medicines or steroids, and either they didn't work well enough, stopped working, or caused too many side effects. Alternatively, you might be eligible if you've developed a dependency on steroid medication, or if nutritional therapy hasn't been effective.
However, some things would mean you can't take part. For example, if your Crohn's disease has caused complications like blockages in the gut that might need surgery soon, or if you have an abscess (a collection of pus). You also couldn't join if you’ve had certain types of bowel surgery in the last few months.
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.
- I have been diagnosed with Crohn's disease.
- My Crohn's disease currently causes moderate to severe symptoms.
- I have tried other Crohn's medicines (like immune suppressors or steroids) and they didn't work well, stopped working, or caused bad side effects.
- I haven't had any recent surgeries on my bowel (within the last few months).
- I do not have any abscesses or severe bowel blockages due to Crohn's.
ماذا يتضمن المشاركة؟
If you decide to take part in this study, you would first go through some checks to make sure the study is right for you. This might involve physical exams, blood tests, and an endoscopy (a procedure where a thin, flexible tube with a camera is used to look inside your digestive system) to confirm the level of activity of your Crohn's disease. If you qualify, you or your child would then receive the study medication, guselkumab. The exact way this medicine is given (e.g., by injection) and how often would be explained to you in detail by the study team. You would have regular visits to the clinic for assessments, which include checking your symptoms, blood tests, and sometimes further endoscopies. The study aims to follow how you respond to the treatment over 52 weeks (about one year).
المخاطر والفوائد المحتملة
المواقع (85)
- مركز سيدرز سيناي الطبيالرمز البريدي المؤكدلوس أنجلوس، الولايات المتحدة· التوظيف
- Connecticut Children's Medical Centerالرمز البريدي المؤكدهارتفورد، الولايات المتحدة· مكتمل
- جامعة إيموريالرمز البريدي المؤكدأتلانتا، الولايات المتحدة· التوظيف
- Children's Center for Digestive Health Careالرمز البريدي المؤكدأتلانتا، الولايات المتحدة· التوظيف
- Riley Hospital for Childrenالرمز البريدي المؤكدإنديانابوليس، الولايات المتحدة· مكتمل
- Boston Childrens Hospitalالرمز البريدي المؤكدبوسطن، الولايات المتحدة· التوظيف
- Goryeb Children's Hospitalالرمز البريدي المؤكدمورستاون، الولايات المتحدة· التوظيف
- Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Centerالرمز البريدي المؤكدنيويورك، الولايات المتحدة· التوظيف
- كلية إيكان للطب في جبل سيناءالرمز البريدي المؤكدنيويورك، الولايات المتحدة· التوظيف
- مركز كولومبيا الطبي الجامعيالرمز البريدي المؤكدنيويورك، الولايات المتحدة· مكتمل
- The Children's Medical Center of Daytonالرمز البريدي المؤكدDayton, United States· مكتمل
- مستشفى الأطفال في فيلادلفياالرمز البريدي المؤكدفيلادلفيا، الولايات المتحدة· التوظيف
أسئلة شائعة
ما هو الجوسلكوماب؟
Guselkumab is an investigational medicine being tested to see if it can help reduce inflammation in Crohn’s disease.
كم ستستغرق مدة الدراسة؟
The main part of this study will last for about 52 weeks, which is roughly one year.
Will I know if I'm getting the active medicine or a placebo?
The study design will be explained fully by the research team; in some phases of trials, it's common for participants to receive the active drug rather than a placebo in studies of this type.
What happens if guselkumab doesn't work for me?
The study team will regularly monitor your condition, and if the treatment isn't working or your condition worsens, they will discuss your options for further care.
هل يجب علي الدفع للمشاركة في الدراسة؟
No, all study-related treatments and assessments are usually provided free of charge.
كيفية معرفة المزيد
جهة الاتصال للدراسة
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
مدعوم من منتدانا في community.patient.info. يرجى التحلي بالاحترام — هذه ليست نصيحة طبية.