Comparison of azathioprine to methotrexate in combination therapy with adalimumab in Crohn’s Disease: an open-label randomized controlled trial

Prior treatment

• Use of any investigational drug within 30 days
• Previous intolerance to thiopurines or MTX
• Previous exposition to adalimumab

Other illness

• Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (<3 months)
• Others serious simultaneous illness that could interfere with study participation

Other

• 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

• 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