A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease
This study is about a medicine called risankizumab for people with Crohn's disease, a condition that causes inflammation in the gut. We're trying to understand how effective and safe risankizumab is when used over a longer period, especially for those who have already shown improvement with it. The study involves different groups looking at various things: some will compare risankizumab to a dummy drug to see how well it keeps people feeling better, others will look at different ways of taking the medicine, and some will follow people for a long time to check for any side effects. We're also checking how easy it is for people to use a special device to give themselves the medicine. The aim is to find the best and safest ways to manage Crohn's disease with risankizumab.
Auf einen Blick
Worum geht es in dieser Studie?
This research project is all about a medicine called risankizumab, which is being studied for people living with Crohn's disease. Crohn's disease is a condition where parts of your digestive system become inflamed, causing a lot of discomfort and other health problems. The main goal of this extended study is to carefully check if risankizumab continues to work well and if it's safe over a longer period, especially for those who have already seen some benefits from it in earlier studies.
The study is split into different parts. Some parts compare risankizumab to a 'placebo' (a dummy treatment with no active medicine) to see how effective it is at keeping Crohn's symptoms under control. Other parts look at different ways of giving the medicine and how much medicine is needed to keep people feeling their best. There's also a part that follows people for a very long time to make sure risankizumab remains safe and to understand its long-term effects. We're also curious about how easy and comfortable it is for people to give themselves the medicine using a special device.
Ultimately, this study aims to gather important information that can help doctors and patients make informed decisions about treating Crohn's disease in the future. By understanding more about risankizumab, we hope to improve the quality of life for people with this condition. It's important to remember that all medicines have potential benefits and risks, and this study helps us understand both for risankizumab.
Wichtige Erkenntnisse
- This study is for people who have already responded well to risankizumab for Crohn's disease.
- It aims to check the long-term safety and effectiveness of risankizumab.
- Different ways of taking the medicine, including a self-injecting device, are being tested.
- You will get close medical attention and monitoring if you participate.
- It's a chance to potentially continue on a new treatment for your Crohn's.
- You can stop participating at any time if you change your mind.
Wer könnte berechtigt sein?
To join this study, you would generally need to have taken part in and successfully completed one of the previous risankizumab studies for Crohn's disease (specifically M16-006 or M15-991, or another AbbVie risankizumab Crohn's study) and shown a positive response to the treatment. This means the medicine had a good effect on your Crohn's disease during the earlier part of your treatment.
For one specific part of the study (Sub-study 4), you would also need to be already receiving risankizumab as ongoing treatment in Sub-study 3 for at least 16 weeks, without needing additional 'rescue' treatment, and be willing to give yourself injections using a special device called an 'on-body injector'. You also need to be between 16 and 80 years old, and the study is open to both men and women.
You would not be able to join if you had certain serious health issues found in previous studies, such as high-grade colon changes or cancer, or if you had a severe allergic reaction to risankizumab or its ingredients. Other reasons for not being able to join include having certain infections, a history of problems with your immune system (like lymphoma), or being pregnant. Your study doctor would carefully check all your medical information to make sure this study is right for you.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Have I previously completed a risankizumab study for Crohn's disease (like M16-006 or M15-991)?
- Did I show improvement in my Crohn's disease with risankizumab in that previous study?
- Am I between 16 and 80 years old?
- Am I willing to come for regular clinic visits and tests?
- Am I comfortable with the idea of giving myself injections with a special device, if required for my study group?
Was beinhaltet die Teilnahme?
If you decide to join this study, what you do will depend on which part of the study you are in. Generally, you would receive risankizumab, either through a drip (IV) or as an injection under the skin (SC), or sometimes a dummy treatment (placebo). You might also learn how to use a special 'on-body injector' to give yourself the medicine at home.
Throughout the study, you would have regular visits to the clinic. These visits would involve health checks, blood tests, and sometimes other tests to see how your Crohn's disease is doing and to check for any side effects. You'd also be asked to answer questions about how you're feeling and how the treatment is affecting your daily life. The study could last for an extended period, as some parts involve long-term follow-up to see how the medicine works over years. The research team will explain your specific schedule in detail.
Potenzielle Risiken und Vorteile
Locations (496)
- Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884Verifizierte PostleitzahlMesa, Vereinigte Staaten
- Phoenix VA Health Care System /ID# 162264Verifizierte PostleitzahlPhoenix, Vereinigte Staaten
- Banner - University Medical Center Tucson /ID# 158502Verifizierte PostleitzahlTucson, Vereinigte Staaten
- Atria Clinical Research /ID# 164505Verifizierte PostleitzahlLittle Rock, Vereinigte Staaten
- Southern California Res. Ctr. /ID# 211991Verifizierte PostleitzahlCoronado, United States
- Duplicate_Newport Huntington Medical Group /ID# 213035Verifizierte PostleitzahlHuntington Beach, Vereinigte Staaten
- UC San Diego Health Systems /ID# 155555Verifizierte PostleitzahlLa Jolla, Vereinigte Staaten
- United Medical Doctors /ID# 207888Verifizierte PostleitzahlLos Alamitos, Vereinigte Staaten
- TLC Clinical Research Inc /ID# 212719Verifizierte PostleitzahlLos Angeles, Vereinigte Staaten
- Gastrointestinal Biosciences Clinical Trials /ID# 162657Verifizierte PostleitzahlLos Angeles, Vereinigte Staaten
- United Medical Doctors - Murrieta /ID# 158300Verifizierte PostleitzahlMurrieta, United States
- University of California San Francisco - Mission Bay /ID# 157127Verifizierte PostleitzahlSan Francisco, Vereinigte Staaten
Häufige Fragen
Was ist Morbus Crohn?
Crohn's disease is a long-term condition that causes inflammation in your digestive system, which can lead to tummy pain, diarrhoea, and weight loss.
What is risankizumab?
Risankizumab is a medicine being studied to help reduce the inflammation caused by Crohn's disease.
Werde ich definitiv das aktive Medikament erhalten?
In some parts of the study, you might receive the active medicine (risankizumab), while in others, you might receive a placebo (a dummy treatment). This is needed to fairly test if the medicine works.
What is an 'on-body injector'?
It's a special device that sticks to your skin and slowly delivers the medicine over time, allowing you to give yourself doses at home instead of having to go to a clinic for every injection.
Wie lange wird die Studie dauern?
The study involves different parts, some of which include long-term follow-up, so it could last for several years to see the continued effects of the medicine.
Wie Sie mehr erfahren können
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
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