Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
Guselkumab: Guselkumab will be administered IV and SC.
Study summary
The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.
Eligibility
Primary outcome measure(s)
- Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than (<)11 in All Intestinal Segments at Week 48 — At Week 48
Percentage of participants achieving a MaRIA \<11 in all intestinal segments at Week 48 will be reported. The MaRIA scoring system is used to grade severity in Crohn's Disease (CD) by assessing ileocolonic CD activity on contrast-enhanced magnetic resonance imaging (MRI) enterography. Active disease is defined as a MaRIA score greater than or equal to (\>=)7 whereas severe disease is defined as a MaRIA score \>=11.
Trial sites (84)
| Facility | City | Region | Status |
|---|---|---|---|
| Center for Colitis and Crohns Disease University of California | San Francisco | California | |
| The University of Chicago Medical Center (UCMC) | Chicago | Illinois | |
| Washington University School Of Medicine | St Louis | Missouri | |
| Medical University of South Carolina | Charleston | South Carolina | |
| The Queen Elizabeth Hospital | Adelaide | Australia | |
| Concord Repatriation General Hospital | Concord | Australia | |
| Northern Hospital | Melbourne | Australia | |
| Fiona Stanley Hospital | Murdoch | Australia | |
| Mater Hospital Brisbane | South Brisbane | Australia | |
| AZ Maria Middelares | Ghent | Belgium | |
| CHU de Liege | Liège | Belgium | |
| Vitaz | Sint-Niklaas | Belgium | |
| Cliged | Macaé | Brazil | |
| Instituto Mederi de Pesquisa e Saude | Passo Fundo | Brazil | |
| NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre | Brazil | |
| INTEGRAL Pesquisa e Ensino | Votuporanga | Brazil | |
| Foothills Hospital | Calgary | Alberta | |
| Western University & London Health Sciences Centre | London | Ontario | |
| Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | |
| Nemocnice Ceske Budejovice a s | České Budějovice | Czechia | |
| Hepato-gastroenterologie HK, s.r.o. | Hradec Králové | Czechia | |
| ISCARE a.s. | Prague | Czechia | |
| CHU Amiens Picardie | Amiens | France | |
| CHU de Clermont Ferrand | Clermont-Ferrand | France | |
| CHRU de Lille Hopital Claude Huriez | Lille | France | |
| Aphm - Hopital Nord | Marseille | France | |
| CHU de Nantes hotel Dieu | Nantes | France | |
| APHP - Hopital Bichat - Claude Bernard | Paris | France | |
| Klinikum Augsburg | Augsburg | Germany | |
| Charite Universitaetsmedizin Berlin | Berlin | Germany | |
| Praxis Fur Gastroenteroligie | Berlin | Germany | |
| Medizinisches Versorgungszentrum (MVZ) Dachau | Dachau | Germany | |
| Universitatsklinikum Frankfurt/ Medizinische Klinik 1 | Frankfurt | Germany | |
| Universitatsmedizin Gottingen | Göttingen | Germany | |
| Studiengesellschaft Mitteldeutschland GmbH | Halle | Germany | |
| Medizinische Hochschule Hannover | Hanover | Germany | |
| Universitatsklinikum Schleswig Holstein | Kiel | Germany | |
| Staedtisches Klinikum Lueneburg | Lüneburg | Germany | |
| MVZ Portal 10 | Münster | Germany | |
| Siloah St Trudpert Klinikum | Pforzheim | Germany |
+ 44 more sites — see the full list on the official registry below.
On this site
📄 Tremfya (guselkumab) drug profile →More Janssen-Cilag Ltd. trials in Australia
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06408935 on ClinicalTrials.gov ↗ ← All trials in Australia