Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
146
Countries
1
Sites
22
patient with moderate to severe Crohn's disease with at least one active perianal fistula track
Key facts
- Sponsor
- Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 16 Nov 2020 → ongoing
- Decision date (initial)
- 2024-08-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503380-42-00
- EudraCT number
- 2019-001337-13
- ClinicalTrials.gov
- NCT04496063
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
patient with moderate to severe Crohn's disease with at least one active perianal fistula track
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
- Sponsor organisation
- Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
- Address
- 50 Rue Richer
- City
- Paris
- Postcode
- 75009
- Country
- France
Scientific contact point
- Organisation
- Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
- Contact name
- Justine Pollet
Public contact point
- Organisation
- Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif
- Contact name
- Justine Pollet
Locations
1 EU/EEA country · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 146 | 22 |
| Rest of world | — | 0 | — |
Investigational sites
Hopital Beaujon
GASTROENTEROLOGIE, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire De Rennes
GASTROENTEROLOGIE, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Saint Etienne
GASTROENTEROLOGIE, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Nice
GASTROENTEROLOGIE, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Montpellier
GASTROENTEROLOGIE, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Assistance Publique Hopitaux De Paris
gastroenterology, 178 Rue Des Renouillers, 92701, Colombes Cedex
Centre Hospitalier Universitaire De Lille
GASTROENTEROLOGIE, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Hospices Civils De Lyon
GASTROENTEROLOGIE, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
University Hospital Of Clermont-Ferrand
GASTROENTEROLOGIE, 28 Place Henri Dunant, Bp 30038, Clermont Ferrand Cedex 1
CHU Besancon
GASTROENTEROLOGIE, 3 Boulevard Alexandre Fleming, 25000, Besancon
Hopital Saint Antoine
GASTROENTEROLOGIE, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospitalier De Roubaix
GASTROENTEROLOGIE, 35 Rue De Barbieux, 59100, Roubaix
Centre Hospitalier Universitaire De Nantes
GASTROENTEROLOGIE, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire Amiens Picardie
gastroenterology, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Medico Chirurgical Ambroise Pare Hartmann
GASTROENTEROLOGIE, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
CHRU De Nancy
GASTROENTEROLOGIE, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Centre Hospitalier Regional Universitaire De Tours
GASTROENTEROLOGIE, Avenue De La Republique, 37170, Chambray Les Tours
Centre Hospitalier Universitaire De Nimes
GASTROENTEROLOGIE, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Assistance Publique Hopitaux De Paris
gastroenterology, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Maison de la Santé Protestante de Bagatelle
gastroenterology, 203, route de Toulouse, Talence
Hopital Saint Louis
GASTROENTEROLOGIE, 1 Avenue Claude Vellefaux, 75010, Paris
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
GASTROENTEROLOGIE, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2020-11-16 | 2020-11-16 | 2024-06-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-09 | France | Acceptable 2024-08-07
|
2024-08-28 |