A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Crohn Disease
Спонсор: Janssen Research & Development, LLC
Налично на:
БГ
Обобщение
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.
Кой може да участва
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
Места на провеждане
26
Австралия (1)
Monash Health, Monash Medical Centre
Clayton
Белгия (1)
OLV Ziekenhuis Aalst
Aalst
Bosnia and Herzegovina (1)
University hospital Clinical centre Banja Luka
Banja Luka
Бразилия (1)
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu
Канада (1)
London Health Sciences Centre
London , Ontario
Китай (1)
The Affiliated Hospital of Bengbu Medical College
Bengbu
Хърватия (1)
Opca bolnica Bjelovar
Bjelovar
Чехия (1)
Fakultni nemocnice Brno
Brno
Дания (1)
Sydvestjysk Sygehus
Esbjerg
Франция (1)
Centre Hospitalier de la Cote Basque
Bayonne
Унгария (1)
Obudai Egeszsegugyi Centrum Kft
Budapest
Израел (1)
Haemek Medical Center
Afula
Италия (1)
Policlinico Sant'Orsola Malpighi
Bologna
Япония (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
Нидерландия (1)
Onze Lieve Vrouwe Gasthuis
Amsterdam
New Zealand (1)
Christchurch Hospital
Christchurch
Полша (1)
Gastromed Kralisz Romatowski Stachurska Sp. j.
Bialystok
Словакия (1)
FNsP F.D.R. Banska Bystrica
Banská Bystrica
Южна Корея (1)
Kyungpook National University Chilgok Hospital
Busan
Испания (1)
Hosp. de Cabuenes
Gijón
Taiwan (1)
Kaohsiung Medical University Chung Ho Memorial Hospital