A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
Phase 3 – large-scale trial before approval
Conditions:
Crohn Disease
Sponsor: Janssen Research & Development, LLC
trial.available_in:
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Overview
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Who can participate
Inclusion Criteria:
* Diagnosis of Crohn's disease (CD) of at least 3 months in duration
* Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Exclusion Criteria:
* Current diagnosis of ulcerative colitis or indeterminate colitis
* Complications of Crohn's disease that require surgical intervention or confound efficacy assessments
* Unstable doses of concomitant Crohn's disease therapy
Locations
26
Australia (1)
Monash Health, Monash Medical Centre
Clayton
Belgium (1)
OLV Ziekenhuis Aalst
Aalst
Bosnia and Herzegovina (1)
University hospital Clinical centre Banja Luka
Banja Luka
Brazil (1)
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu
Canada (1)
London Health Sciences Centre
London , Ontario
China (1)
The Affiliated Hospital of Bengbu Medical College
Bengbu
Croatia (1)
Opca bolnica Bjelovar
Bjelovar
Czech Republic (1)
Fakultni nemocnice Brno
Brno
Denmark (1)
Sydvestjysk Sygehus
Esbjerg
France (1)
Centre Hospitalier de la Cote Basque
Bayonne
Hungary (1)
Obudai Egeszsegugyi Centrum Kft
Budapest
Israel (1)
Haemek Medical Center
Afula
Italy (1)
Policlinico Sant'Orsola Malpighi
Bologna
Japan (1)
Juntendo University Hospital
Bunkyō City
Jordan (1)
Khalidi Hospital and Medical Center
Amman
Lithuania (1)
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas
Malaysia (1)
Hospital Sultanah Aminah
Johor Bharu
Netherlands (1)
Onze Lieve Vrouwe Gasthuis
Amsterdam
New Zealand (1)
Christchurch Hospital
Christchurch
Poland (1)
Gastromed Kralisz Romatowski Stachurska Sp. j.
Bialystok
Slovakia (1)
FNsP F.D.R. Banska Bystrica
Banská Bystrica
South Korea (1)
Kyungpook National University Chilgok Hospital
Busan
Spain (1)
Hosp. de Cabuenes
Gijón
Taiwan (1)
Kaohsiung Medical University Chung Ho Memorial Hospital
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