Comparison of azathioprine to methotrexate in combination therapy with adalimumab in Crohn’s Disease: an open-label randomized controlled trial
Key facts
- Where
- Amiens Cedex 1, Aurillac Cedex, Bayonne, Besancon Cedex, Caen, Clermont-Ferrand, Clichy, Colmar Cedex, Creteil Cedex, Lille, Montpellier Cedex 5, Nantes, Neuilly-Sur-Seine, Nice, Paris Cedex 10, Pessac, Pierre-Bénite, Reims Cedex, Rennes, Roubaix, Rouen Cedex, St Etienne Cedex 2, Toulon, Toulouse Cedex 9, Tourcoing Cedex, Tours, Valence és Vandoeuvre Les Nancy, FranciaországSee the 28 sites
- Phase
- 3. fázis
Where in Franciaország
- Centre Hospitalier Universitaire Amiens PicardieAmiens Cedex 1, FranciaországTaking people
- Centre Hospitalier Henri MondorAurillac Cedex, FranciaországTaking people
- Centre Hospitalier de la Cote BasqueBayonne, FranciaországTaking people
- CHU BesanconBesancon Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire de Caen NormandieCaen, FranciaországTaking people
- University Hospital Of Clermont-FerrandClermont-Ferrand, FranciaországTaking people
- Hopital BeaujonClichy, FranciaországTaking people
- Centre Hospitalier De ColmarColmar Cedex, FranciaországTaking people
- Centre Hospitalier Intercommunal CreteilCreteil Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire de LilleLille, FranciaországTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranciaországTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranciaországTaking people
- Centre Medico Chirurgical Ambroise Pare HartmannNeuilly-Sur-Seine, FranciaországTaking people
- Centre Hospitalier Universitaire de NiceNice, FranciaországTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 10, FranciaországTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranciaországTaking people
- Hospices Civils de LyonPierre-Bénite, FranciaországTaking people
- Centre Hospitalier Universitaire ReimsReims Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranciaországTaking people
- Centre hospitalier de RoubaixRoubaix, FranciaországTaking people
- Centre Hospitalier Universitaire RouenRouen Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire De Saint EtienneSt Etienne Cedex 2, FranciaországTaking people
- Centre Hospitalier Intercommunal Toulon / La Seine-Sur-MerToulon, FranciaországTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranciaországTaking people
- Centre Hospitalier De TourcoingTourcoing Cedex, FranciaországTaking people
- Centre Hospitalier Régional Universitaire de ToursTours, FranciaországTaking people
- Centre Hospitalier ValenceValence, FranciaországTaking people
- CHRU De NancyVandoeuvre Les Nancy, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire Amiens Picardie
- Trial code
- EU 2024-514633-38-00
- Record updated
- 2026. szeptember 30.
- Original description
To compare the endoscopic response to AZA and to MTX in combination with adalimumab in patients with CDRead full original descriptionShow less
To compare the endoscopic response to AZA and to MTX in combination with adalimumab in patients with CD
Inclusion: Male or female patients with age > 18 years; CD for at least 6 weeks; Clinically active with CDAI > 150; Active inflammation by endoscopy (SES-CD ≥6 (or in isolated ileum disease SES-CD ≥4)) at baseline; Not responder to conventional therapy (steroids and/or immunosuppressants) or are intolerant to or have medical contraindications for such therapies and initiating treatment with adalimumab; Patient followed in a centre belonging to the GETAID network; Fertile men and women of childbearing potential included in the protocol should use adequate methods of contraception according to study drug SMPCs.
Exclusion: Use of any investigational drug within 30 days; Previous intolerance to thiopurines or MTX; Previous exposition to adalimumab; Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (<3 months); Others serious simultaneous illness that could interfere with study participation; Adults protected by law; Non-passable colonic stricture; Contra-indication to adalimumab; Contra-indication to immunosuppressants or anti-TNF; Planning pregnancy, pregnancy or lactation or absence of contraception; Known substance abusers.