Informations générales (source: ClinicalTrials.gov)

NCT03464097 Active, sans recrutement
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Interventional
  • Maladie de Crohn
Phase 3
juin 2018
mars 2026
10 juillet 2024
This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CHI DE CRETEIL Hervé HAGEGE En recrutement IDF 29/03/2024 01:28:49  Contacter
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Local Institution - 507 - 34295 - Montpellier - France Contact (sur clinicalTrials)
Local Institution - 612 - 76031 - Rouen Cedex - France Contact (sur clinicalTrials)
Local Institution - 615 - 38700 - Grenoble Cedex 9 - France Contact (sur clinicalTrials)
Local Institution - 616 - 21079 - Dijon Cedex - France Contact (sur clinicalTrials)
Local Institution - 630 - 69495 - Pierre-Benite - France Contact (sur clinicalTrials)
Local Institution - 631 - 42270 - Saint Priest en Jarez - France Contact (sur clinicalTrials)
Local Institution - 632 - 44093 - Nantes - France Contact (sur clinicalTrials)
Local Institution - 633 - 59037 - Lillie Cedex - France Contact (sur clinicalTrials)
Local Institution - 634 - 14000 - Caen - France Contact (sur clinicalTrials)
Local Institution - 635 - 41016 - Blois Cedex - France Contact (sur clinicalTrials)
Local Institution - 638 - 80054 - Amiens cedex 1 - France Contact (sur clinicalTrials)
Local Institution - 639 - 34525 - Béziers - France Contact (sur clinicalTrials)
Local Institution - 641 - 35033 - Rennes - France Contact (sur clinicalTrials)
Local Institution - 643 - 31059 - Toulouse Cedex 09 - France Contact (sur clinicalTrials)
Local Institution - 644 - 92701 - Colombes - France Contact (sur clinicalTrials)
Local Institution - 646 - 13915 - Marseille cedex 20 - France Contact (sur clinicalTrials)
Local Institution - 647 - 92200 - Neuilly-sur-Seine - Cedex - France Contact (sur clinicalTrials)
Local Institution - 711 - 94010 - Creteil Cedex - France Contact (sur clinicalTrials)

Critères

Tous
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit: www.BMSStudyConnect.com

Inclusion Criteria:

- Fulfilled the inclusion criteria at time of entry into the induction study and
completed the week 12 efficacy assessments of the induction study

- In clinical response and/or clinical remission and/or an average daily stool
frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and
stool frequency no worse than baseline at Week 12 of the Induction Study

Exclusion Criteria:

- Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the
induction studies or has developed a symptomatic fistula

- Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids,
immunomodulatory agents, investigational agents or apheresis

Other protocol-defined inclusion/exclusion criteria apply