Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease

Inclusion criteria

• Age > 18 years
• Active CD (CDAI>220) and signs of active inflammation as evidenced by elevated serum hsCRP levels (>5 mg/L) and/or elevated fecal calprotectin levels (>250 µg/g) and endoscopically visible ulcers.
• Patients must be naïve to biologics with indication for starting anti-TNF therapy in accordance with national reimbursement criteria.
• Patients must be naïve to thiopurines or have failed therapy with thiopurines (in which case AZA will be continued).
• Ongoing steroids are allowed if at stable dose for at least 2 weeks and at a maximum of prednisone 40 mg/d or budesonide 9 mg/day.
• Patients who consent to receiving Infliximab 5 mg/kg at week 0, 2 and 6 and further on every 8 weeks in conjunction with azathioprine (2,5 mg/kg/day). Patients who develop AZA intolerance during the trial are continued in the trial without AZA (ie IFX monotherapy).

Exclusion criteria

• Absence of endoscopically visible ulcers
• Prior exposure to infliximab (other biologics allowed)
• Ongoing steroid therapy at doses > 40 mg/d prednisolone equivalent
• Previous intolerance to azathioprine leading to drug discontinuation
• Ongoing infections
• Positive tuberculosis screen per local guidelines
• Serious other diseases including cancer in the 5 years prior to inclusion excluding non-melanoma skin cancer
• Indication for immediate surgery
• Pregnant or breast-feeding woman.
• Positive fecal culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools
• Active tuberculosis
• Untreated latent tuberculosis (see national recommendations. Appendix 2).
• Non-compliant subjects.
• Participation in another therapeutic study.