Clinical trial • Gastroenterology
ustekinumab for Crohn's disease | Perianal fistulising Crohn's disease
Clinical trial of ustekinumab for Crohn's disease | Perianal fistulising Crohn's disease. 146 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Crohn's disease | Perianal fistulising Crohn's disease
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 09-07-2024
- First CTIS Authorization Date
- 28-08-2024
Trial design
Clinical trial across 22 sites in France.
- Target Sample Size
- 146
Eligibility
Recruits 146 No vulnerable populations selected (isVulnerablePopulationSelected: false). Consent/assent handling not specified in the available record..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Consent/assent handling not specified in the available record.
Recruitment
- Planned Sample Size
- 146
- Recruitment Window Months
- 43
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 146
France
- Earliest CTIS Part Ii Submission Date
- 19-08-2024
- Latest Decision Or Authorization Date
- 28-08-2024
- Processing Time Days
- 9
- Number Of Sites
- 22
- Number Of Participants
- 146
Sites
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Xavier Hébuterne
- Principal Investigator Email
- hebuterne.x@chu-nice.fr
- Contact Person Name
- Xavier Hébuterne
- Contact Person Email
- hebuterne.x@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Ludovic Caillo
- Principal Investigator Email
- ludovic.caillo@chu-nimes.fr
- Contact Person Name
- Ludovic Caillo
- Contact Person Email
- ludovic.caillo@chu-nimes.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Philippe SEKSIK
- Principal Investigator Email
- philippe.seksik@aphp.fr
- Contact Person Name
- Philippe SEKSIK
- Contact Person Email
- philippe.seksik@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Stéphane Nancey
- Principal Investigator Email
- stephane.nancey@chu-lyon.fr
- Contact Person Name
- Stéphane Nancey
- Contact Person Email
- stephane.nancey@chu-lyon.fr
- Site Name
- Centre Medico Chirurgical Ambroise Pare Hartmann
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Yoram Bouhnik
- Principal Investigator Email
- yoram.bouhnik@institutdesmici.fr
- Contact Person Name
- Yoram Bouhnik
- Contact Person Email
- yoram.bouhnik@institutdesmici.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- gastroenterology
- Principal Investigator Name
- Mathurin Fumery
- Principal Investigator Email
- fumery.mathurin@chu-amiens.fr
- Contact Person Name
- Mathurin Fumery
- Contact Person Email
- fumery.mathurin@chu-amiens.fr
- Site Name
- Centre Hospitalier De Roubaix
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Nicolas Duveau
- Principal Investigator Email
- nicolas.duveau@ch-roubaix.fr
- Contact Person Name
- Nicolas Duveau
- Contact Person Email
- nicolas.duveau@ch-roubaix.fr
- Site Name
- Maison de la Santé Protestante de Bagatelle
- Department Name
- gastroenterology
- Principal Investigator Name
- François Pigot
- Principal Investigator Email
- proctobagatelle@mspb.com
- Contact Person Name
- François Pigot
- Contact Person Email
- proctobagatelle@mspb.com
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Laurence Picon
- Principal Investigator Email
- l.picon@chu-tours.fr
- Contact Person Name
- Laurence Picon
- Contact Person Email
- l.picon@chu-tours.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Anne-Laure Pelletier
- Principal Investigator Email
- anne-laure.pelletier@aphp.fr
- Contact Person Name
- Anne-Laure Pelletier
- Contact Person Email
- anne-laure.pelletier@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Pauline Wils
- Principal Investigator Email
- pauline.wils@chru-lille.fr
- Contact Person Name
- Pauline Wils
- Contact Person Email
- pauline.wils@chru-lille.fr
- Site Name
- CHU Besancon
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Lucine Vuitton
- Principal Investigator Email
- lvuitton@chu-besancon.fr
- Contact Person Name
- Lucine Vuitton
- Contact Person Email
- lvuitton@chu-besancon.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Guillaume Bouguen
- Principal Investigator Email
- guillaume.bouguen@chu-rennes.fr
- Contact Person Name
- Guillaume Bouguen
- Contact Person Email
- guillaume.bouguen@chu-rennes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- gastroenterology
- Principal Investigator Name
- Benoit Coffin
- Principal Investigator Email
- benoit.coffin@aphp.fr
- Contact Person Name
- Benoit Coffin
- Contact Person Email
- benoit.coffin@aphp.fr
- Site Name
- Hopital Saint Louis
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- MATHIEU ALLEZ
- Principal Investigator Email
- mathieu.allez@chu-nantes.fr
- Contact Person Name
- MATHIEU ALLEZ
- Contact Person Email
- mathieu.allez@chu-nantes.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- ANTHONY BUISSON
- Principal Investigator Email
- a_buisson@chu-clermontferrand.fr
- Contact Person Name
- ANTHONY BUISSON
- Contact Person Email
- a_buisson@chu-clermontferrand.fr
- Site Name
- CHRU De Nancy
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Laurent Peyrin-Biroulet
- Principal Investigator Email
- xxxx@xxxx.fr
- Contact Person Name
- Laurent Peyrin-Biroulet
- Contact Person Email
- xxxx@xxxx.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Arnaud BOUREILLE
- Principal Investigator Email
- arnaud.boureille@chu-nantes.fr
- Contact Person Name
- Arnaud BOUREILLE
- Contact Person Email
- arnaud.boureille@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Xavier Roblin
- Principal Investigator Email
- xavier.roblin@chu-st-etienne.fr
- Contact Person Name
- Xavier Roblin
- Contact Person Email
- xavier.roblin@chu-st-etienne.fr
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Calina Atanasiu
- Principal Investigator Email
- xxxx@xxx.fr
- Contact Person Name
- Calina Atanasiu
- Contact Person Email
- xxxx@xxx.fr
- Site Name
- Hopital Beaujon
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Manon Haas
- Principal Investigator Email
- xxxx@xxx.fr
- Contact Person Name
- Manon Haas
- Contact Person Email
- xxxx@xxx.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- GASTROENTEROLOGIE
- Principal Investigator Name
- Romain Altwegg
- Principal Investigator Email
- r-altwegg@chu-montpellier.fr
- Contact Person Name
- Romain Altwegg
- Contact Person Email
- r-altwegg@chu-montpellier.fr
Sponsor
Primary sponsor
- Full Name
- Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- USTekinumab
- Active Substance
- ustekinumab
- Modality
- Monoclonal antibody
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